Magnetic Resonance Imaging
Conditions
Keywords
Gadolinium, Pediatrics, MRI, contrast
Brief summary
The main purpose of this study is to collect data on the way gadobutrol is taken into, moves around, and is eliminated from, the body of children aged 0 to less than 2 years. The study will also evaluate safety and tolerability, and efficacy of gadobutrol. A maximum total amount of approximately 5 ml of blood will be needed for these analyses which will be drawn within 2-3 days. Gadobutrol is a contrast agent used for enhancement of Magnetic Resonance Imaging (MRI), potentially allowing better visibility of tissues in the body. Children aged under 2 years scheduled for a routine contrast-enhanced MRI examination of any body region may take part in this study, in which case they will receive gadobutrol as contrast agent intravenously at the standard dose of 0.1 mmol/kg (0.1 ml/Kg) of body weight. Only subjects without renal insufficiency of any intensity (i.e. estimated Glomerular Filtration Rate \<80% of age adjusted normal value calculated based on the Schwartz formula) will be included in the trial. The duration of this study as a whole is around 1 year and the total number of children to be enrolled is 50. A child will be expected to take part in the study for around 7 days.
Interventions
Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants \<2 years of age.
Sponsors
Bayer
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
Inclusion criteria
* Pediatric subjects aged \<2 years (term newborn infants to toddlers 23 months of age inclusive) * Subject is scheduled to undergo routine gadolinium-enhanced MRI of any body region
Exclusion criteria
* Subjects undergoing a change in chemotherapy within 48 hours prior to and up to 24 hours after gadobutrol injection * Any planned intervention during the study and up to 24 hours after gadobutrol injection (excluding lumbar puncture) * Subjects who received or will receive any investigational product within 48 hours before gadobutrol injection or during study participation * Subjects who received or will receive any other contrast agent within 48 hours prior to gadobutrol injection or up to 24 hours after gadobutrol injection * Subjects with contraindication for MRI such as iron metal implants (e.g. aneurysm clips) * History of anaphylactoid or anaphylactic reaction to any allergen including drugs and contrast agents * Subject with renal insufficiency of any intensity, i.e. estimated Glomerular Filtration Rate \<80% of age adjusted normal value calculated based on the Schwartz formula
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Simulation of Plasma Concentration of Gadobutrol at 30 Minutes Post-Injection (C30) | 30 minutes post-injection | Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C30 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented. |
| Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Infinity of Gadobutrol: Individual | Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol | AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC from time 0 (start of injection) to infinity was reported in micromole\*hour per liter (micromole\*h/L). |
| Body Weight-Normalized Total Body Clearance (CL) of Gadobutrol From Plasma: Individual | Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol | Clearance is the volume of the fluid presented to the eliminating organ that is effectively completely cleared of drug per unit time and depends on the rate of elimination. CL of gadobutrol normalized for body weight, was reported in Liter per hour per kilogram (L/(h\*kg). |
| Body Weight-Normalized Apparent Volume of Distribution at Steady State (Vss) of Gadobutrol in Plasma: Individual | Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol | Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state. |
| Mean Residence Time (MRT) of Gadobutrol in Plasma: Individual | Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol | MRT is the average time that the molecules introduced into the body stay in the body. MRT of Gadobutrol is expressed in hours. |
| Terminal Elimination Half-Life (t1/2) of Gadobutrol From Plasma: Individual | Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol | Half-life refers to the elimination of the drug, that is, the time it takes for the blood plasma concentration to reach half the concentration. Terminal elimination half-life of gadobutrol from plasma is expressed in hours and is derived from the terminal slope of the concentration versus time curve. |
| Simulation of Plasma Concentration of Gadobutrol at 20 Minutes Post-Injection (C20) | 20 minutes post-injection | Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C20 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Presence of Pathology by Body Region | Images were taken pre-injection and post-injection (within about 15 minutes) | Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as yes/no. The number of lesions identified for each MRI set was recorded. Results per body region were reported. |
| Number of Subjects With Number of Lesions Detected | Images were taken pre-injection and post-injection (within about 15 minutes) | Presence of pathology included presence of lesions and was recorded as yes/no. If yes the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images. |
| Number of Subjects With Number of Lesions Detected by Body Region | Images were taken pre-injection and post-injection (within about 15 minutes) | Presence of pathology included presence of lesions and was recorded as yes/no. If yes the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images. Data of subjects with missing number of lesions or at least one lesion in unenhanced and combined MRI sets were reported. |
| Contrast Enhancement in Lesion or Vessel | Images were taken pre-injection and post-injection (within about 15 minutes) | The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Evaluation was done on pre-injection and combined (pre- and post-injection) images. |
| Contrast Enhancement in Lesion or Vessel by Body Region | Images were taken pre-injection and post-injection (within about 15 minutes) | The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. |
| Number of Subjects With Border Delineation of Lesion of Vessel | Images were taken pre-injection and post-injection (within about 15 minutes) | The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.Evaluation was done on pre-injection and combined (pre- and post-injection) images. |
| Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Images were taken pre-injection and post-injection (within about 15 minutes) | The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.The results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. |
| Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement | Images were taken pre-injection and post-injection (within about 15 minutes) | The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1= Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes.Evaluation was done on pre-injection and combined (pre- and post-injection) images. |
| Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Images were taken pre-injection and post-injection (within about 15 minutes) | The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1 = Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. |
| Number of Subjects With Diagnoses | Images were taken pre-injection and post-injection (within about 15 minutes) | The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Evaluation was done on pre- injection and combined (pre- and post-injection) images. |
| Number of Subjects With Diagnoses by Body Region | Images were taken pre-injection and post-injection (within about 15 minutes) | The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. |
| Number of Subjects With Additional Diagnostic Gain | Images were taken pre-injection and post-injection (within about 15 minutes) | Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Evaluation was done on combined (pre- and post- injection) images. |
| Number of Subjects With Additional Diagnostic Gain by Body Region | Images were taken pre-injection and post-injection (within about 15 minutes) | Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. |
| Number of Subjects With Confidence in Diagnosis | Images were taken pre-injection and post-injection (within about 15 minutes) | Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 1 = Not confident, 2 = Confident and 3 = Very confident. Evaluation was done on pre-injection and combined (pre- and post-injection) images. |
| Number of Subjects With Confidence in Diagnosis by Body Region | Images were taken pre-injection and post-injection (within about 15 minutes) | Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 3 = Very confident, 2 = Confident, and 1 = Not confident. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. |
| Number of Subjects With Final Diagnosis | Up to 4 weeks post-injection | The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Evaluation was done on pre-injection and combined (pre- and post- injection) images. |
| Number of Subjects With Final Diagnosis by Body Region | Up to 4 weeks post-injection | The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. Only subjects with final diagnosis were reported. |
| Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI | Images were taken pre-injection and post-injection (within about 15 minutes) | The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images. |
| Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis | Images were taken pre-injection and post-injection (within about 15 minutes) | The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images. |
| Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region | Images were taken pre-injection and post-injection (within about 15 minutes) | The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. |
| Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis | Images were taken pre-injection and post-injection (within about 15 minutes) | The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images. |
| Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region | Images were taken pre-injection and post-injection (within about 15 minutes) | The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. |
| Number of Subjects With Change in Management From Unenhanced to Combined MRI | Images were taken pre-injection and post-injection (within about 15 minutes) | The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as yes/no. Evaluation was done on pre-injection and combined (pre- and post-injection) images. |
| Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region | Images were taken pre-injection and post-injection (within about 15 minutes) | The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. |
| Number of Subjects With Clinically Significant Abnormal Laboratory Values | Baseline (not exceeding 24 hours before Gadobutrol injection) up to 24 hours post injection | Change in post-injection test values, such as resulting in a change in subject management or which were not the result of laboratory error and were considered clinically significant by the investigator was reported. |
| Estimated Glomerular Filtration Rate (eGFR) Prior to Gadobutrol Injection | Before gadobutrol injection | eGFR was calculated based on the Schwartz formula with blood sampling for serum creatinine (Scr) not exceeding 14 days prior to gadobutrol injection. Otherwise, the eGFR was obtained from the original Schwartz formula: eGFR = k \* height / Scr where k = 0.45 in term newborn infants \< 1 year of age, and k = 0.55 in children up to 13 years of age. If Scr was measured by an enzymatic creatinine method that had been calibrated to be traceable to Isotope dilution mass spectroscopy (IDMS), the updated Schwartz formula was used: eGFR = 0.413\*height/Scr. |
| Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region | Images were taken pre-injection and post-injection (within about 15 minutes) | The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. |
| Number of Subjects With Anatomical Area Evaluated | Images were taken pre-injection and post-injection (within about 15 minutes) | Subjects were referred for MRI of any body region. The primary anatomical area to be evaluated by MRI was assessed. Anatomical Area was recorded prior to gadobutrol injection for the unenhanced MRI procedure and after gadobutrol injection for the gadobutrol-enhanced MRI procedure. Evaluation was done on pre-injection and combined (pre- and post-injection) images. |
| Number of Subjects With Technical Adequacy for Diagnosis | Images were taken pre-injection and post-injection (within about 15 minutes) | The technical adequacy of the unenhanced image set and the combined unenhanced and enhanced image set was assessed based on the following 4 point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined (pre- and post-injection) images. |
| Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Images were taken pre-injection and post-injection (within about 15 minutes) | The technical adequacy of the the unenhanced image set and the combined unenhanced and enhanced image set was assessed based 4-point scale and body region. Four-point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined images. |
| Number of Subjects by Overall Contrast Quality | Images were taken post-injection (within about 15 minutes) | A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done. This parameter was assessed in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported. |
| Number of Subjects by Overall Contrast Quality by Body Region | Images were taken post-injection (within about 15 minutes) | A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported. |
| Number of Subjects With Presence of Pathology | Images were taken pre-injection and post-injection (within about 15 minutes) | Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as yes/no. The number of lesions identified for each MRI set was recorded. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Subjects With Drug Related Serious and Non- Serious Adverse Events | From baseline to approximately 7 days after injection | An Adverse Event (AE) was any untoward medical occurrence in a subject who received study drug. A Serious AE (SAE) was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly, or deemed significant for any other reason. The drug-relatedness of AEs was determined by the Investigator based on his/her clinical decision based on all available information, and was based on the question whether there was a reasonable causal relationship to the study treatment. |
Countries
Canada, Germany, United States
Participant flow
Recruitment details
Pediatric subjects who were less than (\<) 2 years of age, scheduled to undergo contrast-enhanced magnetic resonance imaging (MRI) for routine diagnostic purposes were included in the study and were recruited from 9 centres in Canada, Germany and United States of America.
Pre-assignment details
Total of 47 subjects were screened worldwide in the study and 44 were enrolled (i.e. assigned to study drug). It included 3 screening failures (3 patients were not treated and did not complete the study).
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Single intravenous bolus injection of gadobutrol 0.1 mmol/kg BW in term newborns to infants \<2 years of age. | 44 |
| Total | 44 |
Baseline characteristics
| Characteristic | Overall Study |
|---|---|
| Age, Continuous | 8.8 months STANDARD_DEVIATION 7.1 |
| Age, Customized Infants and toddlers (28 days-23 months) | 39 Participants |
| Age, Customized Newborns (0-27 days) | 5 Participants |
| Sex: Female, Male Female | 18 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 17 / 44 |
| serious Total, serious adverse events | 3 / 44 |
Outcome results
Primary
Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Infinity of Gadobutrol: Individual
AUC is a measure of systemic drug exposure, which is obtained by collecting a series of blood samples and measuring the concentrations of drug in each sample. AUC from time 0 (start of injection) to infinity was reported in micromole\*hour per liter (micromole\*h/L).
Time frame: Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Population: Per-protocol set (PPS) included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Area Under the Plasma Concentration Versus Time Curve (AUC) From Time 0 to Infinity of Gadobutrol: Individual | 776 micromole*h/L |
Primary
Body Weight-Normalized Apparent Volume of Distribution at Steady State (Vss) of Gadobutrol in Plasma: Individual
Vss is an estimate of drug distribution independent of the elimination process and is proportional to the amount of drug in the body versus the drug plasma concentration at steady-state.
Time frame: Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Population: PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Body Weight-Normalized Apparent Volume of Distribution at Steady State (Vss) of Gadobutrol in Plasma: Individual | 0.277 L/kg |
Primary
Body Weight-Normalized Total Body Clearance (CL) of Gadobutrol From Plasma: Individual
Clearance is the volume of the fluid presented to the eliminating organ that is effectively completely cleared of drug per unit time and depends on the rate of elimination. CL of gadobutrol normalized for body weight, was reported in Liter per hour per kilogram (L/(h\*kg).
Time frame: Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Population: PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Body Weight-Normalized Total Body Clearance (CL) of Gadobutrol From Plasma: Individual | 0.128 L/(h*kg) |
Primary
Mean Residence Time (MRT) of Gadobutrol in Plasma: Individual
MRT is the average time that the molecules introduced into the body stay in the body. MRT of Gadobutrol is expressed in hours.
Time frame: Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Population: PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Mean Residence Time (MRT) of Gadobutrol in Plasma: Individual | 2.18 hours |
Primary
Simulation of Plasma Concentration of Gadobutrol at 20 Minutes Post-Injection (C20)
Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C20 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented.
Time frame: 20 minutes post-injection
Population: PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample. Here number of subjects analysed= 43. C20 was simulated for 2400 virtual paediatric participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Simulation of Plasma Concentration of Gadobutrol at 20 Minutes Post-Injection (C20) | 339 micromole/L |
Primary
Simulation of Plasma Concentration of Gadobutrol at 30 Minutes Post-Injection (C30)
Simulation is the use of the model to predict data other than observed data, in this case early Gadobutrol plasma concentration after intravenous injection. Plasma concentration serves as a surrogate for efficacy (signal and contrast enhancement) in MRI. C30 was simulated for virtual pediatric subjects with homogenous distribution over age. Simulated median (5th and 95th percentile in parenthesis) gadolinium plasma concentrations for a dose of 0.1 mmol/kg body weight were presented.
Time frame: 30 minutes post-injection
Population: PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample. C30 was simulated for 2400 virtual paediatric participants.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Simulation of Plasma Concentration of Gadobutrol at 30 Minutes Post-Injection (C30) | 292 micromole/L |
Primary
Terminal Elimination Half-Life (t1/2) of Gadobutrol From Plasma: Individual
Half-life refers to the elimination of the drug, that is, the time it takes for the blood plasma concentration to reach half the concentration. Terminal elimination half-life of gadobutrol from plasma is expressed in hours and is derived from the terminal slope of the concentration versus time curve.
Time frame: Blood samples were collected at 3 timepoints between 15 minutes and 8 hours post administration of gadobutrol
Population: PPS included those subjects who received the appropriate dose of gadobutrol based on the dose specification of 0.1 mmol/kg BW plus/minus 10% and had quantifiable gadolinium plasma concentrations in at least 1 valid PK sample.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Overall Study | Terminal Elimination Half-Life (t1/2) of Gadobutrol From Plasma: Individual | 1.62 hours |
Secondary
Contrast Enhancement in Lesion or Vessel
The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Contrast Enhancement in Lesion or Vessel | None | 44 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel | Moderate | 0 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel | Good | 0 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel | Excellent | 0 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel | Excellent | 35 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel | None | 3 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel | Good | 6 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel | Moderate | 0 subjects |
Secondary
Contrast Enhancement in Lesion or Vessel by Body Region
The contrast-enhancement for each lesion or vessel was recorded on a 4-point scale: 1 = None, lesion or vessel is not enhanced; 2 = Moderate, lesion or vessel is weakly enhanced; 3 = Good, lesion or vessel is clearly enhanced; 4 = Excellent, lesion or vessel is clearly and brightly enhanced. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Head/Neck: Excellent | 0 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Blood vessel: Excellent | 0 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Lymphatic system: None | 1 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Brain: Excellent | 0 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Lymphatic system: Excellent | 0 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Abdomen: None | 1 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Pelvic area: None | 2 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Chest/Thorax: None | 2 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Pelvic area: Good | 0 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Brain: None | 19 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Retroperitoneal: None | 7 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Chest/Thorax: Good | 0 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Retroperitoneal: Excellent | 0 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Head/Neck: None | 5 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Spine: None | 5 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Blood vessel: None | 2 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Spine: Good | 0 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Head/Neck: Good | 0 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Spine: Excellent | 0 subjects |
| Overall Study | Contrast Enhancement in Lesion or Vessel by Body Region | Brain: Good | 0 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Spine: Excellent | 4 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Chest/Thorax: Good | 1 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Abdomen: None | 1 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Blood vessel: Excellent | 2 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Brain: None | 0 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Brain: Good | 1 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Brain: Excellent | 18 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Chest/Thorax: None | 1 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Head/Neck: None | 0 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Head/Neck: Good | 1 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Head/Neck: Excellent | 4 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Lymphatic system: None | 0 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Lymphatic system: Excellent | 1 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Pelvic area: None | 0 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Pelvic area: Good | 2 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Retroperitoneal: None | 1 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Retroperitoneal: Excellent | 6 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Spine: None | 0 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Spine: Good | 1 subjects |
| Combined MRI Assessment | Contrast Enhancement in Lesion or Vessel by Body Region | Blood vessel: None | 0 subjects |
Secondary
Estimated Glomerular Filtration Rate (eGFR) Prior to Gadobutrol Injection
eGFR was calculated based on the Schwartz formula with blood sampling for serum creatinine (Scr) not exceeding 14 days prior to gadobutrol injection. Otherwise, the eGFR was obtained from the original Schwartz formula: eGFR = k \* height / Scr where k = 0.45 in term newborn infants \< 1 year of age, and k = 0.55 in children up to 13 years of age. If Scr was measured by an enzymatic creatinine method that had been calibrated to be traceable to Isotope dilution mass spectroscopy (IDMS), the updated Schwartz formula was used: eGFR = 0.413\*height/Scr.
Time frame: Before gadobutrol injection
Population: SAF included all subjects who received any amount of gadobutrol. Here n included subjects who were evaluable at specified age group.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Overall Study | Estimated Glomerular Filtration Rate (eGFR) Prior to Gadobutrol Injection | < 1 month (n=5) | 61.8 milliliter/minute/1.73 square | Standard Deviation 19.2 |
| Overall Study | Estimated Glomerular Filtration Rate (eGFR) Prior to Gadobutrol Injection | 1 to < 2 months (n=4) | 91.7 milliliter/minute/1.73 square | Standard Deviation 24.8 |
| Overall Study | Estimated Glomerular Filtration Rate (eGFR) Prior to Gadobutrol Injection | 2 to < 6 months (n=9) | 136.3 milliliter/minute/1.73 square | Standard Deviation 67.1 |
| Overall Study | Estimated Glomerular Filtration Rate (eGFR) Prior to Gadobutrol Injection | 6 to < 12 months (n=11) | 115.2 milliliter/minute/1.73 square | Standard Deviation 45.9 |
| Overall Study | Estimated Glomerular Filtration Rate (eGFR) Prior to Gadobutrol Injection | 12 to < 24 months (n=15) | 150.4 milliliter/minute/1.73 square | Standard Deviation 33.9 |
Secondary
Number of Subjects by Overall Contrast Quality
A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done. This parameter was assessed in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported.
Time frame: Images were taken post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects by Overall Contrast Quality | Excellent | 38 subjects |
| Overall Study | Number of Subjects by Overall Contrast Quality | None | 1 subjects |
| Overall Study | Number of Subjects by Overall Contrast Quality | Poor | 0 subjects |
| Overall Study | Number of Subjects by Overall Contrast Quality | Moderate | 0 subjects |
| Overall Study | Number of Subjects by Overall Contrast Quality | Good | 5 subjects |
Secondary
Number of Subjects by Overall Contrast Quality by Body Region
A qualitative assessment of the overall contrast using the following pre-defined 5-point scale: 1= None (for example, in case of a non-enhancing vessel), 2= Poor, 3= Moderate, 4= Good, 5= Excellent, was done in the postcontrast MRI only, which is evaluated together with the unenhanced, this is why it is called combined. Data for combined MRI set was reported.
Time frame: Images were taken post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects by Overall Contrast Quality by Body Region | Abdomen: Excellent | 1 subjects |
| Overall Study | Number of Subjects by Overall Contrast Quality by Body Region | Brain: Excellent | 19 subjects |
| Overall Study | Number of Subjects by Overall Contrast Quality by Body Region | Brain: Good | 2 subjects |
| Overall Study | Number of Subjects by Overall Contrast Quality by Body Region | Chest/Thorax: Good | 1 subjects |
| Overall Study | Number of Subjects by Overall Contrast Quality by Body Region | Chest/Thorax: Excellent | 1 subjects |
| Overall Study | Number of Subjects by Overall Contrast Quality by Body Region | Head/Neck: Excellent | 5 subjects |
| Overall Study | Number of Subjects by Overall Contrast Quality by Body Region | Lymphatic system: Excellent | 1 subjects |
| Overall Study | Number of Subjects by Overall Contrast Quality by Body Region | Pelvic area: Excellent | 2 subjects |
| Overall Study | Number of Subjects by Overall Contrast Quality by Body Region | Retroperitoneal: None | 1 subjects |
| Overall Study | Number of Subjects by Overall Contrast Quality by Body Region | Retroperitoneal: Good | 1 subjects |
| Overall Study | Number of Subjects by Overall Contrast Quality by Body Region | Retroperitoneal: Excellent | 5 subjects |
| Overall Study | Number of Subjects by Overall Contrast Quality by Body Region | Spine: Good | 1 subjects |
| Overall Study | Number of Subjects by Overall Contrast Quality by Body Region | Spine: Excellent | 4 subjects |
Secondary
Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement
The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1= Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes.Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement | Poor | 6 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement | Moderate | 11 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement | Good | 27 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement | Poor | 1 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement | Moderate | 0 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement | Good | 43 subjects |
Secondary
Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region
The degree of visualization of internal morphology and structure was recorded on a 3-point scale: 1 = Poor, the structure and internal morphology of the lesion or vessel is poorly visible; 2 = Moderate, the structure and internal morphology of the lesion or vessel is visible but sufficient information cannot be obtained; 3 = Good, the structure and internal morphology of the lesion or vessel is sufficiently visible for diagnostic purposes. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Chest/Thorax: Moderate | 1 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Chest/Thorax: Good | 1 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Abdomen: Good | 1 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Blood vessel: Good | 2 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Brain: Poor | 1 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Brain: Moderate | 5 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Brain: Good | 13 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Head/Neck: Poor | 1 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Head/Neck: Good | 4 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Lymphatic system: Good | 1 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Pelvic area: Moderate | 2 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Pelvic area: Good | 0 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Retroperitoneal: Poor | 3 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Retroperitoneal: Good | 4 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Spine: Poor | 1 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Spine: Moderate | 3 subjects |
| Overall Study | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Spine: Good | 1 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Spine: Poor | 0 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Head/Neck: Good | 5 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Retroperitoneal: Good | 6 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Retroperitoneal: Poor | 1 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Abdomen: Good | 1 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Lymphatic system: Good | 1 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Blood vessel: Good | 2 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Spine: Good | 5 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Brain: Poor | 0 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Pelvic area: Moderate | 0 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Brain: Moderate | 0 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Spine: Moderate | 0 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Brain: Good | 19 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Chest/Thorax: Moderate | 0 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Chest/Thorax: Good | 2 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Pelvic area: Good | 2 subjects |
| Combined MRI Assessment | Number of Subjects by Visualization of Lesion-Internal Morphology or Homogeneity of Vessel Enhancement by Body Region | Head/Neck: Poor | 0 subjects |
Secondary
Number of Subjects With Additional Diagnostic Gain
Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Evaluation was done on combined (pre- and post- injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Additional Diagnostic Gain | Scale 1 | 19 subjects |
| Overall Study | Number of Subjects With Additional Diagnostic Gain | Scale 2 | 24 subjects |
| Overall Study | Number of Subjects With Additional Diagnostic Gain | Scale 3 | 1 subjects |
Secondary
Number of Subjects With Additional Diagnostic Gain by Body Region
Additional diagnostic gain by the contrast-enhanced image set was assessed on a 3-point scale: scale 1 = Initial diagnosis unchanged, scale 2 = Initial diagnosis changed - improved, i.e. more specific, and scale 3 = Initial diagnosis changed -new diagnosis. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Additional Diagnostic Gain by Body Region | Chest/Thorax: Scale 2 | 2 subjects |
| Overall Study | Number of Subjects With Additional Diagnostic Gain by Body Region | Retroperitoneal: Scale 1 | 3 subjects |
| Overall Study | Number of Subjects With Additional Diagnostic Gain by Body Region | Retroperitoneal: Scale 2 | 4 subjects |
| Overall Study | Number of Subjects With Additional Diagnostic Gain by Body Region | Abdomen: Scale 2 | 1 subjects |
| Overall Study | Number of Subjects With Additional Diagnostic Gain by Body Region | Brain: Scale 1 | 11 subjects |
| Overall Study | Number of Subjects With Additional Diagnostic Gain by Body Region | Brain: Scale 2 | 9 subjects |
| Overall Study | Number of Subjects With Additional Diagnostic Gain by Body Region | Brain: Scale 3 | 1 subjects |
| Overall Study | Number of Subjects With Additional Diagnostic Gain by Body Region | Head/Neck: Scale 1 | 3 subjects |
| Overall Study | Number of Subjects With Additional Diagnostic Gain by Body Region | Head/Neck: Scale 2 | 2 subjects |
| Overall Study | Number of Subjects With Additional Diagnostic Gain by Body Region | Lymphatic system: Scale 2 | 1 subjects |
| Overall Study | Number of Subjects With Additional Diagnostic Gain by Body Region | Pelvic area: Scale 2 | 2 subjects |
| Overall Study | Number of Subjects With Additional Diagnostic Gain by Body Region | Spine: Scale 1 | 2 subjects |
| Overall Study | Number of Subjects With Additional Diagnostic Gain by Body Region | Spine: Scale 2 | 3 subjects |
Secondary
Number of Subjects With Anatomical Area Evaluated
Subjects were referred for MRI of any body region. The primary anatomical area to be evaluated by MRI was assessed. Anatomical Area was recorded prior to gadobutrol injection for the unenhanced MRI procedure and after gadobutrol injection for the gadobutrol-enhanced MRI procedure. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Anatomical Area Evaluated | Chest/thorax: Lung | 2 subjects |
| Overall Study | Number of Subjects With Anatomical Area Evaluated | Abdomen: Liver | 1 subjects |
| Overall Study | Number of Subjects With Anatomical Area Evaluated | Brain: Brain | 20 subjects |
| Overall Study | Number of Subjects With Anatomical Area Evaluated | Brain: Orbit and brain | 1 subjects |
| Overall Study | Number of Subjects With Anatomical Area Evaluated | Head/neck: Head | 3 subjects |
| Overall Study | Number of Subjects With Anatomical Area Evaluated | Head/neck: Neck | 1 subjects |
| Overall Study | Number of Subjects With Anatomical Area Evaluated | Head/neck: Skull base/mandible | 1 subjects |
| Overall Study | Number of Subjects With Anatomical Area Evaluated | Lymphatic system: Right arm | 1 subjects |
| Overall Study | Number of Subjects With Anatomical Area Evaluated | Pelvic area:Trochanter major, femur neck | 1 subjects |
| Overall Study | Number of Subjects With Anatomical Area Evaluated | Pelvic area: Testis | 1 subjects |
| Overall Study | Number of Subjects With Anatomical Area Evaluated | Retroperitoneal: Kidney | 6 subjects |
| Overall Study | Number of Subjects With Anatomical Area Evaluated | Retroperitoneal: Adrenal gland | 1 subjects |
| Overall Study | Number of Subjects With Anatomical Area Evaluated | Spine: Spinal cord | 4 subjects |
| Overall Study | Number of Subjects With Anatomical Area Evaluated | Spine: Lumbar spine | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Anatomical Area Evaluated | Retroperitoneal: Kidney | 6 subjects |
| Combined MRI Assessment | Number of Subjects With Anatomical Area Evaluated | Chest/thorax: Lung | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Anatomical Area Evaluated | Head/neck: Neck | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Anatomical Area Evaluated | Lymphatic system: Right arm | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Anatomical Area Evaluated | Abdomen: Liver | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Anatomical Area Evaluated | Spine: Spinal cord | 4 subjects |
| Combined MRI Assessment | Number of Subjects With Anatomical Area Evaluated | Brain: Brain | 20 subjects |
| Combined MRI Assessment | Number of Subjects With Anatomical Area Evaluated | Pelvic area:Trochanter major, femur neck | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Anatomical Area Evaluated | Brain: Orbit and brain | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Anatomical Area Evaluated | Retroperitoneal: Adrenal gland | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Anatomical Area Evaluated | Head/neck: Head | 3 subjects |
| Combined MRI Assessment | Number of Subjects With Anatomical Area Evaluated | Pelvic area: Testis | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Anatomical Area Evaluated | Spine: Lumbar spine | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Anatomical Area Evaluated | Head/neck: Skull base/mandible | 1 subjects |
Secondary
Number of Subjects With Border Delineation of Lesion of Vessel
The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel | Good | 9 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel | Moderate | 6 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel | None | 5 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel | Excellent | 24 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel | None | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel | Excellent | 42 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel | Moderate | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel | Good | 1 subjects |
Secondary
Number of Subjects With Border Delineation of Lesion of Vessel by Body Region
The border delineation for each lesion or vessel was recorded on a 4-point scale: 1 = None, no or unclear delineation of the boundary between the lesion or vessel and the surrounding tissue; 2 = Moderate, some aspects of border delineation covered; 3 = Good, almost clear delineation, but not complete on relevant slices; 4 = Excellent, clear and complete delineation.The results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Brain: Excellent | 10 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Pelvic area: Excellent | 1 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Blood vessel: Excellent | 2 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Retroperitoneal: None | 3 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Chest/Thorax: Good | 1 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Retroperitoneal: Excellent | 4 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Abdomen: Excellent | 1 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Spine: None | 2 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Chest/Thorax: Excellent | 1 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Spine: Moderate | 2 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Brain: Moderate | 3 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Spine: Excellent | 1 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Lymphatic system: Excellent | 1 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Head/Neck: Good | 2 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Brain: Good | 6 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Head/Neck: Excellent | 3 subjects |
| Overall Study | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Pelvic area: Moderate | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Head/Neck: Excellent | 4 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Brain: Good | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Abdomen: Excellent | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Blood vessel: Excellent | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Brain: Excellent | 19 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Chest/Thorax: Good | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Chest/Thorax: Excellent | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Lymphatic system: Excellent | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Pelvic area: Moderate | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Pelvic area: Excellent | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Retroperitoneal: None | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Retroperitoneal: Excellent | 6 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Spine: None | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Spine: Moderate | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Spine: Excellent | 5 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Head/Neck: Good | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Border Delineation of Lesion of Vessel by Body Region | Brain: Moderate | 0 subjects |
Secondary
Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis
The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis | No | 32 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis | Yes | 12 subjects |
Secondary
Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region
The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region | Lymphatic system: Yes | 1 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region | Pelvic area: No | 1 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region | Pelvic area: Yes | 1 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region | Abdomen: No | 1 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region | Abdomen: Yes | 0 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region | Brain: No | 16 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region | Brain: Yes | 5 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region | Chest/Thorax: No | 1 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region | Chest/Thorax: Yes | 1 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region | Head/Neck: No | 4 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region | Head/Neck: Yes | 1 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region | Lymphatic system: No | 0 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region | Retroperitoneal: No | 5 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region | Retroperitoneal: Yes | 2 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region | Spine: No | 4 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Combined MRI to Final Diagnosis by Body Region | Spine: Yes | 1 subjects |
Secondary
Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis
The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis | No | 33 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis | Yes | 11 subjects |
Secondary
Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region
The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region | Abdomen: No | 1 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region | Abdomen: Yes | 0 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region | Brain: No | 17 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region | Brain: Yes | 4 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region | Chest/Thorax: No | 1 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region | Chest/Thorax: Yes | 1 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region | Head/Neck: No | 4 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region | Head/Neck: Yes | 1 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region | Lymphatic system: No | 0 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region | Lymphatic system: Yes | 1 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region | Pelvic area: No | 1 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region | Pelvic area: Yes | 1 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region | Retroperitoneal: No | 5 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region | Retroperitoneal: Yes | 2 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region | Spine: No | 4 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced MRI to Final Diagnosis by Body Region | Spine: Yes | 1 subjects |
Secondary
Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI
The analysis value for change in diagnosis was recorded as yes/no. Evaluation was done on pre- injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI | No | 39 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI | Yes | 5 subjects |
Secondary
Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region
The analysis value for change in diagnosis was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region | Brain: No | 20 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region | Abdomen: No | 1 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region | Abdomen: Yes | 0 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region | Brain: Yes | 1 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region | Chest/Thorax: No | 2 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region | Chest/Thorax: Yes | 0 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region | Head/Neck: No | 5 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region | Head/Neck: Yes | 0 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region | Lymphatic system: No | 1 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region | Lymphatic system: Yes | 0 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region | Pelvic area: No | 0 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region | Pelvic area: Yes | 2 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region | Retroperitoneal: No | 5 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region | Retroperitoneal: Yes | 2 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region | Spine: No | 5 subjects |
| Overall Study | Number of Subjects With Change in Diagnosis From Unenhanced to Combined MRI by Body Region | Spine: Yes | 0 subjects |
Secondary
Number of Subjects With Change in Management From Unenhanced to Combined MRI
The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as yes/no. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI | No | 36 subjects |
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI | Yes | 8 subjects |
Secondary
Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region
The subject management was indicated based on the unenhanced images alone. The analysis value for change in subject management was recorded as yes/no. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: FAS included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region | Abdomen: No | 1 subjects |
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region | Abdomen: Yes | 0 subjects |
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region | Brain: No | 19 subjects |
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region | Brain: Yes | 2 subjects |
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region | Chest/Thorax: No | 2 subjects |
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region | Chest/Thorax: Yes | 0 subjects |
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region | Head/Neck: No | 5 subjects |
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region | Head/Neck: Yes | 0 subjects |
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region | Lymphatic system: No | 1 subjects |
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region | Lymphatic system: Yes | 0 subjects |
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region | Pelvic area: No | 0 subjects |
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region | Pelvic area: Yes | 2 subjects |
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region | Retroperitoneal: No | 3 subjects |
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region | Retroperitoneal: Yes | 4 subjects |
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region | Spine: No | 5 subjects |
| Overall Study | Number of Subjects With Change in Management From Unenhanced to Combined MRI by Body Region | Spine: Yes | 0 subjects |
Secondary
Number of Subjects With Clinically Significant Abnormal Laboratory Values
Change in post-injection test values, such as resulting in a change in subject management or which were not the result of laboratory error and were considered clinically significant by the investigator was reported.
Time frame: Baseline (not exceeding 24 hours before Gadobutrol injection) up to 24 hours post injection
Population: Safety Analysis Set (SAF) included all subjects who received any amount of gadobutrol.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Overall Study | Number of Subjects With Clinically Significant Abnormal Laboratory Values | 0 subjects |
Secondary
Number of Subjects With Confidence in Diagnosis
Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 1 = Not confident, 2 = Confident and 3 = Very confident. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Confidence in Diagnosis | Not confident | 6 subjects |
| Overall Study | Number of Subjects With Confidence in Diagnosis | Confident | 14 subjects |
| Overall Study | Number of Subjects With Confidence in Diagnosis | Very confident | 24 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis | Not confident | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis | Confident | 3 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis | Very confident | 40 subjects |
Secondary
Number of Subjects With Confidence in Diagnosis by Body Region
Diagnostic confidence based on the unenhanced MRI image sets and thereafter on the combined MRI image sets were assessed on a 3-point scale, as 3 = Very confident, 2 = Confident, and 1 = Not confident. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Confidence in Diagnosis by Body Region | Chest/Thorax: Confident | 1 subjects |
| Overall Study | Number of Subjects With Confidence in Diagnosis by Body Region | Chest/Thorax: Very confident | 1 subjects |
| Overall Study | Number of Subjects With Confidence in Diagnosis by Body Region | Pelvic area: Confident | 0 subjects |
| Overall Study | Number of Subjects With Confidence in Diagnosis by Body Region | Retroperitoneal: Not confident | 3 subjects |
| Overall Study | Number of Subjects With Confidence in Diagnosis by Body Region | Spine: Confident | 2 subjects |
| Overall Study | Number of Subjects With Confidence in Diagnosis by Body Region | Abdomen: Confident | 1 subjects |
| Overall Study | Number of Subjects With Confidence in Diagnosis by Body Region | Brain: Not confident | 1 subjects |
| Overall Study | Number of Subjects With Confidence in Diagnosis by Body Region | Brain: Confident | 8 subjects |
| Overall Study | Number of Subjects With Confidence in Diagnosis by Body Region | Brain: Very confident | 12 subjects |
| Overall Study | Number of Subjects With Confidence in Diagnosis by Body Region | Head/Neck: Confident | 2 subjects |
| Overall Study | Number of Subjects With Confidence in Diagnosis by Body Region | Head/Neck: Very confident | 3 subjects |
| Overall Study | Number of Subjects With Confidence in Diagnosis by Body Region | Lymphatic system: Very confident | 1 subjects |
| Overall Study | Number of Subjects With Confidence in Diagnosis by Body Region | Pelvic area: Not confident | 2 subjects |
| Overall Study | Number of Subjects With Confidence in Diagnosis by Body Region | Retroperitoneal: Very confident | 4 subjects |
| Overall Study | Number of Subjects With Confidence in Diagnosis by Body Region | Spine: Very confident | 3 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis by Body Region | Lymphatic system: Very confident | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis by Body Region | Chest/Thorax: Confident | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis by Body Region | Brain: Very confident | 21 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis by Body Region | Chest/Thorax: Very confident | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis by Body Region | Pelvic area: Confident | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis by Body Region | Spine: Very confident | 5 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis by Body Region | Retroperitoneal: Very confident | 6 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis by Body Region | Head/Neck: Confident | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis by Body Region | Spine: Confident | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis by Body Region | Pelvic area: Not confident | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis by Body Region | Abdomen: Confident | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis by Body Region | Head/Neck: Very confident | 5 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis by Body Region | Brain: Not confident | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis by Body Region | Retroperitoneal: Not confident | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Confidence in Diagnosis by Body Region | Brain: Confident | 0 subjects |
Secondary
Number of Subjects With Diagnoses
The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Evaluation was done on pre- injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Diagnoses | Benign lesion | 1 subjects |
| Overall Study | Number of Subjects With Diagnoses | Inflammation | 2 subjects |
| Overall Study | Number of Subjects With Diagnoses | Vascular malformation | 1 subjects |
| Overall Study | Number of Subjects With Diagnoses | Congenital disease / syndrome | 6 subjects |
| Overall Study | Number of Subjects With Diagnoses | Malignant lesion | 4 subjects |
| Overall Study | Number of Subjects With Diagnoses | No lesion/Normal | 10 subjects |
| Overall Study | Number of Subjects With Diagnoses | Other | 18 subjects |
| Overall Study | Number of Subjects With Diagnoses | Structural malformation | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses | Other | 13 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses | Benign lesion | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses | Malignant lesion | 4 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses | Vascular malformation | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses | Structural malformation | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses | Inflammation | 3 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses | Congenital disease / syndrome | 8 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses | No lesion/Normal | 11 subjects |
Secondary
Number of Subjects With Diagnoses by Body Region
The following diagnoses were reported for both the unenhanced MRI and the combined MRI image sets: Other diagnoses, No lesions/normal, Congenital disease/syndrome, Malignant lesion, Inflammation, Structural malformation, Benign lesion, and Vascular malformation. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Diagnoses by Body Region | Brain: Congenital disease/syndrome | 3 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Retroperitoneal: Malignant lesion | 1 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Retroperitoneal: Congenital disease/syndrome | 3 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Spine: Structural malformation | 1 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Abdomen: Other | 1 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Brain: Malignant lesion | 1 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Brain: Inflammation | 1 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Brain: No lesion/Normal | 9 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Brain: Other | 7 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Chest/Thorax: Structural malformation | 1 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Chest/Thorax: Other | 1 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Head/Neck: Benign lesion | 1 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Head/Neck: Malignant lesion | 1 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Head/Neck: Inflammation | 1 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Head/Neck: Other | 2 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Lymphatic system: Vascular malformation | 1 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Pelvic area: Benign lesion | 0 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Pelvic area: Inflammation | 0 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Pelvic area: Other | 2 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Retroperitoneal: Other | 3 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Spine: Malignant lesion | 1 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Spine: No lesion/Normal | 1 subjects |
| Overall Study | Number of Subjects With Diagnoses by Body Region | Spine: Other | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Head/Neck: Malignant lesion | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Retroperitoneal: Congenital disease/syndrome | 5 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Retroperitoneal: Malignant lesion | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Head/Neck: Inflammation | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Spine: Other | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Head/Neck: Other | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Abdomen: Other | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Retroperitoneal: Other | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Brain: Malignant lesion | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Lymphatic system: Vascular malformation | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Brain: Inflammation | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Brain: Congenital disease/syndrome | 3 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Spine: No lesion/Normal | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Brain: No lesion/Normal | 10 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Pelvic area: Benign lesion | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Brain: Other | 6 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Spine: Malignant lesion | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Chest/Thorax: Structural malformation | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Pelvic area: Inflammation | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Chest/Thorax: Other | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Spine: Structural malformation | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Head/Neck: Benign lesion | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Diagnoses by Body Region | Pelvic area: Other | 0 subjects |
Secondary
Number of Subjects With Final Diagnosis
The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Evaluation was done on pre-injection and combined (pre- and post- injection) images.
Time frame: Up to 4 weeks post-injection
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Final Diagnosis | Structural malformation | 1 subjects |
| Overall Study | Number of Subjects With Final Diagnosis | Other diagnoses | 24 subjects |
| Overall Study | Number of Subjects With Final Diagnosis | Congenital disease/syndrome | 6 subjects |
| Overall Study | Number of Subjects With Final Diagnosis | No lesions/normal | 6 subjects |
| Overall Study | Number of Subjects With Final Diagnosis | Malignant lesions | 4 subjects |
| Overall Study | Number of Subjects With Final Diagnosis | Benign lesions | 2 subjects |
| Overall Study | Number of Subjects With Final Diagnosis | Infectious disease | 1 subjects |
Secondary
Number of Subjects With Final Diagnosis by Body Region
The final diagnosis of the subjects was based on all clinical information available and was provided separately within 4 weeks after MRI. Results per body regions were reported. Evaluation was done on pre-injection and combined (pre- and post-injection) images. Only subjects with final diagnosis were reported.
Time frame: Up to 4 weeks post-injection
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Abdomen: Other | 1 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Retroperitoneal: Malignant lesion | 1 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Chest/ thorax: Congenital disease/syndrome | 3 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Chest/ thorax: Infectious disease | 1 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Chest/ thorax: Malignant lesion | 1 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Chest/ thorax: No lesion/Normal | 6 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Chest/ thorax: Other | 2 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Brain: Other | 10 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Head/neck: Benign lesion | 1 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Head/neck: Malignant lesion | 1 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Head/neck: Other | 3 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Lymphatic system: Other | 1 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Pelvic area: Benign lesion | 1 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Pelvic area: Other | 1 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Retroperitoneal: Congenital disease/syndrome | 3 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Retroperitoneal: Other | 3 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Spine: Malignant lesion | 1 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Spine: Other | 3 subjects |
| Overall Study | Number of Subjects With Final Diagnosis by Body Region | Spine: Structural malformation | 1 subjects |
Secondary
Number of Subjects With Number of Lesions Detected
Presence of pathology included presence of lesions and was recorded as yes/no. If yes the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation. 44 subjects in the FAS were analyzed. The number of subjects with presence of pathology was 33.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Number of Lesions Detected | Number of lesions=missing | 2 subjects |
| Overall Study | Number of Subjects With Number of Lesions Detected | Number of lesions=2 | 2 subjects |
| Overall Study | Number of Subjects With Number of Lesions Detected | Number of lesions=1 | 29 subjects |
| Overall Study | Number of Subjects With Number of Lesions Detected | Number of lesions=10 | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Number of Lesions Detected | Number of lesions=10 | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Number of Lesions Detected | Number of lesions=2 | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Number of Lesions Detected | Number of lesions=missing | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Number of Lesions Detected | Number of lesions=1 | 29 subjects |
Secondary
Number of Subjects With Number of Lesions Detected by Body Region
Presence of pathology included presence of lesions and was recorded as yes/no. If yes the number of subjects with specified lists of lesions and body region was reported. Evaluation was done on pre- injection and combined (pre- and post-injection) images. Data of subjects with missing number of lesions or at least one lesion in unenhanced and combined MRI sets were reported.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation. 44 subjects in the FAS were analyzed. The number of subjects with presence of pathology was 33.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Number of Lesions Detected by Body Region | Spine: 1 lesion | 4 subjects |
| Overall Study | Number of Subjects With Number of Lesions Detected by Body Region | Abdomen: Missing lesion | 1 subjects |
| Overall Study | Number of Subjects With Number of Lesions Detected by Body Region | Brain: 1 lesion | 10 subjects |
| Overall Study | Number of Subjects With Number of Lesions Detected by Body Region | Brain: 2 lesion | 1 subjects |
| Overall Study | Number of Subjects With Number of Lesions Detected by Body Region | Chest/Thorax: 1 lesion | 2 subjects |
| Overall Study | Number of Subjects With Number of Lesions Detected by Body Region | Head/Neck: Missing lesion | 1 subjects |
| Overall Study | Number of Subjects With Number of Lesions Detected by Body Region | Head/Neck: 1 lesion | 4 subjects |
| Overall Study | Number of Subjects With Number of Lesions Detected by Body Region | Head/Neck: 10 lesion | 0 subjects |
| Overall Study | Number of Subjects With Number of Lesions Detected by Body Region | Lymphatic system: 1 lesion | 1 subjects |
| Overall Study | Number of Subjects With Number of Lesions Detected by Body Region | Pelvic area: 1 lesion | 2 subjects |
| Overall Study | Number of Subjects With Number of Lesions Detected by Body Region | Retroperitoneal: 1 lesion | 6 subjects |
| Overall Study | Number of Subjects With Number of Lesions Detected by Body Region | Retroperitoneal: 2 lesion | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Number of Lesions Detected by Body Region | Brain: 2 lesion | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Number of Lesions Detected by Body Region | Head/Neck: 10 lesion | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Number of Lesions Detected by Body Region | Lymphatic system: 1 lesion | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Number of Lesions Detected by Body Region | Spine: 1 lesion | 4 subjects |
| Combined MRI Assessment | Number of Subjects With Number of Lesions Detected by Body Region | Head/Neck: Missing lesion | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Number of Lesions Detected by Body Region | Pelvic area: 1 lesion | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Number of Lesions Detected by Body Region | Abdomen: Missing lesion | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Number of Lesions Detected by Body Region | Head/Neck: 1 lesion | 4 subjects |
| Combined MRI Assessment | Number of Subjects With Number of Lesions Detected by Body Region | Brain: 1 lesion | 10 subjects |
| Combined MRI Assessment | Number of Subjects With Number of Lesions Detected by Body Region | Retroperitoneal: 2 lesion | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Number of Lesions Detected by Body Region | Retroperitoneal: 1 lesion | 6 subjects |
| Combined MRI Assessment | Number of Subjects With Number of Lesions Detected by Body Region | Chest/Thorax: 1 lesion | 2 subjects |
Secondary
Number of Subjects With Presence of Pathology
Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as yes/no. The number of lesions identified for each MRI set was recorded.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Presence of Pathology | Yes | 33 subjects |
| Overall Study | Number of Subjects With Presence of Pathology | No | 11 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology | Yes | 33 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology | No | 11 subjects |
Secondary
Number of Subjects With Presence of Pathology by Body Region
Presence of pathology was assessed for unenhanced and combined MRI sets and recorded as yes/no. The number of lesions identified for each MRI set was recorded. Results per body region were reported.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Presence of Pathology by Body Region | Spine: Yes | 4 subjects |
| Overall Study | Number of Subjects With Presence of Pathology by Body Region | Chest/Thorax: No | 0 subjects |
| Overall Study | Number of Subjects With Presence of Pathology by Body Region | Abdomen: No | 0 subjects |
| Overall Study | Number of Subjects With Presence of Pathology by Body Region | Chest/Thorax: Yes | 2 subjects |
| Overall Study | Number of Subjects With Presence of Pathology by Body Region | Retroperitoneal: No | 0 subjects |
| Overall Study | Number of Subjects With Presence of Pathology by Body Region | Head/Neck: No | 0 subjects |
| Overall Study | Number of Subjects With Presence of Pathology by Body Region | Abdomen: Yes | 1 subjects |
| Overall Study | Number of Subjects With Presence of Pathology by Body Region | Lymphatic system: No | 0 subjects |
| Overall Study | Number of Subjects With Presence of Pathology by Body Region | Spine: No | 1 subjects |
| Overall Study | Number of Subjects With Presence of Pathology by Body Region | Lymphatic system: Yes | 1 subjects |
| Overall Study | Number of Subjects With Presence of Pathology by Body Region | Brain: No | 10 subjects |
| Overall Study | Number of Subjects With Presence of Pathology by Body Region | Pelvic area: No | 0 subjects |
| Overall Study | Number of Subjects With Presence of Pathology by Body Region | Pelvic area: Yes | 2 subjects |
| Overall Study | Number of Subjects With Presence of Pathology by Body Region | Retroperitoneal: Yes | 7 subjects |
| Overall Study | Number of Subjects With Presence of Pathology by Body Region | Brain: Yes | 11 subjects |
| Overall Study | Number of Subjects With Presence of Pathology by Body Region | Head/Neck: Yes | 5 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology by Body Region | Spine: Yes | 4 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology by Body Region | Head/Neck: Yes | 5 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology by Body Region | Pelvic area: No | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology by Body Region | Pelvic area: Yes | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology by Body Region | Spine: No | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology by Body Region | Abdomen: No | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology by Body Region | Abdomen: Yes | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology by Body Region | Brain: No | 10 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology by Body Region | Brain: Yes | 11 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology by Body Region | Chest/Thorax: No | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology by Body Region | Chest/Thorax: Yes | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology by Body Region | Head/Neck: No | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology by Body Region | Lymphatic system: No | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology by Body Region | Lymphatic system: Yes | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology by Body Region | Retroperitoneal: No | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Presence of Pathology by Body Region | Retroperitoneal: Yes | 7 subjects |
Secondary
Number of Subjects With Technical Adequacy for Diagnosis
The technical adequacy of the unenhanced image set and the combined unenhanced and enhanced image set was assessed based on the following 4 point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined (pre- and post-injection) images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Technical Adequacy for Diagnosis | Score = 3 | 4 subjects |
| Overall Study | Number of Subjects With Technical Adequacy for Diagnosis | Score = 4 | 40 subjects |
| Overall Study | Number of Subjects With Technical Adequacy for Diagnosis | Score = 1 | 0 subjects |
| Overall Study | Number of Subjects With Technical Adequacy for Diagnosis | Score = 2 | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Technical Adequacy for Diagnosis | Score = 2 | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Technical Adequacy for Diagnosis | Score = 3 | 3 subjects |
| Combined MRI Assessment | Number of Subjects With Technical Adequacy for Diagnosis | Score = 1 | 0 subjects |
| Combined MRI Assessment | Number of Subjects With Technical Adequacy for Diagnosis | Score = 4 | 41 subjects |
Secondary
Number of Subjects With Technical Adequacy for Diagnosis by Body Region
The technical adequacy of the the unenhanced image set and the combined unenhanced and enhanced image set was assessed based 4-point scale and body region. Four-point scale: 1=Region visualized with artifacts compromising quality and interpretability of images, 2=Only partial evaluation of images possible, region not covered adequately anatomically, 3=Region visualized with artifacts, partially compromising image quality but evaluation and diagnosis still possible, 4=Region clearly visualized, excellent quality. Evaluation was done on pre-injection and combined images.
Time frame: Images were taken pre-injection and post-injection (within about 15 minutes)
Population: Full analysis set (FAS) included all subjects who had combined unenhanced and enhanced image sets available regardless of any other protocol deviation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Spine: Score 3 | 2 subjects |
| Overall Study | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Head/neck: Score 3 | 1 subjects |
| Overall Study | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Brain: Score 3 | 1 subjects |
| Overall Study | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Head/neck: Score 4 | 4 subjects |
| Overall Study | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Pelvic area: Score 4 | 2 subjects |
| Overall Study | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Lymphatic system: Score 4 | 1 subjects |
| Overall Study | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Brain: Score 4 | 20 subjects |
| Overall Study | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Retroperitoneal area: Score 4 | 7 subjects |
| Overall Study | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Chest/thorax: Score 4 | 2 subjects |
| Overall Study | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Spine: Score 4 | 3 subjects |
| Overall Study | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Abdomen: Score 4 | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Spine: Score 4 | 4 subjects |
| Combined MRI Assessment | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Abdomen: Score 4 | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Brain: Score 4 | 20 subjects |
| Combined MRI Assessment | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Lymphatic system: Score 4 | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Retroperitoneal area: Score 4 | 7 subjects |
| Combined MRI Assessment | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Brain: Score 3 | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Chest/thorax: Score 4 | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Head/neck: Score 3 | 1 subjects |
| Combined MRI Assessment | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Head/neck: Score 4 | 4 subjects |
| Combined MRI Assessment | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Pelvic area: Score 4 | 2 subjects |
| Combined MRI Assessment | Number of Subjects With Technical Adequacy for Diagnosis by Body Region | Spine: Score 3 | 1 subjects |
Other Pre-specified
Number of Subjects With Drug Related Serious and Non- Serious Adverse Events
An Adverse Event (AE) was any untoward medical occurrence in a subject who received study drug. A Serious AE (SAE) was an AE resulting in death, initial or prolonged inpatient hospitalization, life-threatening experience, persistent or significant disability/incapacity, congenital anomaly, or deemed significant for any other reason. The drug-relatedness of AEs was determined by the Investigator based on his/her clinical decision based on all available information, and was based on the question whether there was a reasonable causal relationship to the study treatment.
Time frame: From baseline to approximately 7 days after injection
Population: SAF included all subjects who received any amount of gadobutrol.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Overall Study | Number of Subjects With Drug Related Serious and Non- Serious Adverse Events | Any study drug-related AE | 1 subjects |
| Overall Study | Number of Subjects With Drug Related Serious and Non- Serious Adverse Events | Any study drug-related SAE | 0 subjects |