Lesion in Body Region
Conditions
Brief summary
The trial aimed at evaluating the efficacy and the safety of gadopiclenol for body Magnetic resonance Imaging (MRI)
Detailed description
The purpose of this trial was to evaluate a new gadolinium-based contrast agent (GBCA) gadopiclenol in terms of lesion visualization in patients referred for contrast-enhanced MRI of body regions. This is a prospective, international, multi-center, randomized, double-blind, controlled and cross-over trial. This trial was conducted in 33 centers worldwide. During the course of the trial, two MRIs were obtained from each patient: one with gadopiclenol and one with gadobutrol. MRI evaluations were assessed by independent off-site blinded readers.
Interventions
DRUGgadopiclenol
Single intravenous bolus injection
DRUGGadobutrol 1 MMOLE/ML Intravenous Solution
Single intravenous bolus injection
Sponsors
Guerbet
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DIAGNOSTIC
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient presenting with known or suspected enhancing abnormality(ies) and/or lesion(s) in at least one body region based on a previous imaging procedure performed within 12 months prior to ICF signature. US patients are restricted to the breast in compliance with local approved indications of gadobutrol.
Exclusion criteria
* Patient presenting with acute or chronic renal insufficiency, defined as an estimated Glomerular Filtration Rate (eGFR) \< 30 mL/min/1.73 m² assessed within 1 day prior to each contrast agent administration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | At first MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 1. At second MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 2, performed 2-14 days after gadobutrol-enhanced MRI. | The lesion visualization at patient level was based on 3 co-primary criteria on marching lesions: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor \[internal morphology\] or none \[border delineation, contrast enhancement\], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each co-criterion was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between Paired \[unenhanced and contrast-enhanced\] images and Pre-contrast \[unenhanced\] images was calculated for each of the 3 co-primary criteria and for each reader. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | At each of two MRI examinations with an interval of 2-14 days between two MRI examinations | The lesion visualization (per patient) was based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement, assessed on the images performed with gadopiclenol and images performed with gadobutrol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor \[internal morphology\] or none \[border delineation, contrast enhancement\], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each of the 3 lesion visualization co-criteria was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between gadopiclenol scores mean and gadobutrol scores mean was calculated for each of the 3 co-primary criteria and for each reader. |
Countries
Bulgaria, France, Germany, Hungary, Italy, Mexico, Poland, South Korea, Spain, Ukraine, United States
Participant flow
Pre-assignment details
Among the 324 screened patients,19 were screen failure, 1 received the first contrast agent but was not randomized. A total of 304 patients were randomized, of whom 300 (151 in Arm 1 and 149 in Arm 2) received the first contrast agent and underwent the first MRI (First MRI Period). After a washout period of 2-14 days, 277 patients (141 in the Arm 1 and 136 in the Arm 2) received the second contrast agent and underwent the second MRI (Second MRI Period). 275 patients completed the study.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: Gadopiclenol-enhanced MRI for First MRI and Gadobutrol-enhanced MRI for Second MRI Cross-over study design
For each patient in this Arm, he (she) performed the first contrast-enhanced MRI with gadopiclenol as contrast agent (First MRI Period). After a washout period of 2-14 days (Washout Period), the patient performed the second contrast-enhanced MRI with gadobutrol as contrast agent (Second MRI Period).
For each patient, two sets of MR images per MRI examination were obtained: unenhanced and gadopiclenol-enhanced MR images obtained in the First MRI Examination Period, unenhanced and gadobutrol-enhanced MR images obtained in the Second MRI Examination Period. | 145 |
| Arm 2: Gadobutrol-enhanced MRI for First MRI and Gadopiclenol-enhanced MRI for Second MRI Cross-over study design
For each patient in this Arm, he (she) performed the first contrast-enhanced MRI with gadobutrol as contrast agent (First MRI Period). After a washout period of 2-14 days (Washout Period), the patient performed the second contrast-enhanced MRI with gadopiclenol as contrast agent (Second MRI Period).
For each patient, two sets of MR images per MRI examination were obtained: unenhanced and gadobutrol-enhanced MR images obtained in the First MRI Examination Period, unenhanced and gadopiclenol-enhanced MR images obtained in the second MRI Examination Period. | 133 |
| Total | 278 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| First MRI Examination | Other reason (mainly technical issues with MRI machine) | 1 | 2 |
| First MRI Examination | Physician Decision | 0 | 1 |
| Second MRI Examination | Withdrawal by Subject | 0 | 2 |
| Washout | Adverse Event | 1 | 1 |
| Washout | Lost to Follow-up | 0 | 2 |
| Washout | Other reason | 5 | 5 |
| Washout | Withdrawal by Subject | 4 | 5 |
Baseline characteristics
| Characteristic | Arm 2: Gadobutrol-enhanced MRI for First MRI and Gadopiclenol-enhanced MRI for Second MRI | Arm 1: Gadopiclenol-enhanced MRI for First MRI and Gadobutrol-enhanced MRI for Second MRI | Total |
|---|---|---|---|
| Age, Continuous | 56.9 years STANDARD_DEVIATION 13.1 | 57.5 years STANDARD_DEVIATION 12.9 | 57.2 years STANDARD_DEVIATION 13 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 20 Participants | 31 Participants | 51 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 113 Participants | 114 Participants | 227 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 12 Participants | 18 Participants | 30 Participants |
| Race (NIH/OMB) Asian | 22 Participants | 22 Participants | 44 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 2 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 94 Participants | 102 Participants | 196 Participants |
| Region of Enrollment Bulgaria | 9 participants | 2 participants | 11 participants |
| Region of Enrollment France | 2 participants | 8 participants | 10 participants |
| Region of Enrollment Germany | 3 participants | 2 participants | 5 participants |
| Region of Enrollment Hungary | 20 participants | 28 participants | 48 participants |
| Region of Enrollment Italy | 1 participants | 0 participants | 1 participants |
| Region of Enrollment Mexico | 12 participants | 18 participants | 30 participants |
| Region of Enrollment Poland | 35 participants | 32 participants | 67 participants |
| Region of Enrollment South Korea | 22 participants | 22 participants | 44 participants |
| Region of Enrollment Spain | 2 participants | 2 participants | 4 participants |
| Region of Enrollment Ukraine | 9 participants | 4 participants | 13 participants |
| Region of Enrollment United States | 18 participants | 27 participants | 45 participants |
| Sex: Female, Male Female | 82 Participants | 82 Participants | 164 Participants |
| Sex: Female, Male Male | 51 Participants | 63 Participants | 114 Participants |
| Weight | 75.5 Kg STANDARD_DEVIATION 17.1 | 75.3 Kg STANDARD_DEVIATION 17.1 | 75.4 Kg STANDARD_DEVIATION 17.1 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 288 | 0 / 290 |
| other Total, other adverse events | 50 / 288 | 58 / 290 |
| serious Total, serious adverse events | 3 / 288 | 0 / 290 |
Outcome results
Primary
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI
The lesion visualization at patient level was based on 3 co-primary criteria on marching lesions: border delineation, internal morphology and degree of contrast enhancement, assessed on the images acquired during the MRI performed with gadopiclenol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor \[internal morphology\] or none \[border delineation, contrast enhancement\], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each co-criterion was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between Paired \[unenhanced and contrast-enhanced\] images and Pre-contrast \[unenhanced\] images was calculated for each of the 3 co-primary criteria and for each reader.
Time frame: At first MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 1. At second MRI examination (gadopiclenol-enhanced MRI) for patients of Arm 2, performed 2-14 days after gadobutrol-enhanced MRI.
Population: Full Analysis Set (FAS) included a total of 278 patients who had both Pre and Paired images with gadopiclenol assessable for primary criteria for at least one matching lesion for at least one off-site reader: 145 patients in the Arm 1 for whom gadopiclenol-enhanced MRI was performed as first MRI, and 133 patients in the Arm 2 for whom gadopiclenol-enhanced MRI was performed as second MRI. The analysis was based on participants (per patient).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Border delineation - Reader 1 | 3.79 mean of a score (on a scale) per patient | Standard Error 0.03 |
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Border delineation - Reader 2 | 3.48 mean of a score (on a scale) per patient | Standard Error 0.06 |
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Border delineation - Reader 3 | 3.49 mean of a score (on a scale) per patient | Standard Error 0.03 |
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Internal morphology - Reader 1 | 3.80 mean of a score (on a scale) per patient | Standard Error 0.02 |
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Internal morphology - Reader 2 | 3.75 mean of a score (on a scale) per patient | Standard Error 0.05 |
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Internal morphology - Reader 3 | 3.72 mean of a score (on a scale) per patient | Standard Error 0.03 |
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Contrast enhancement - Reader 1 | 3.64 mean of a score (on a scale) per patient | Standard Error 0.03 |
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Contrast enhancement - Reader 2 | 2.82 mean of a score (on a scale) per patient | Standard Error 0.05 |
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Contrast enhancement - Reader 3 | 3.33 mean of a score (on a scale) per patient | Standard Error 0.03 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Border delineation - Reader 1 | 2.26 mean of a score (on a scale) per patient | Standard Error 0.03 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Internal morphology - Reader 3 | 1.69 mean of a score (on a scale) per patient | Standard Error 0.03 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Border delineation - Reader 2 | 3.01 mean of a score (on a scale) per patient | Standard Error 0.06 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Contrast enhancement - Reader 3 | 1.00 mean of a score (on a scale) per patient | Standard Error 0.03 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Border delineation - Reader 3 | 1.78 mean of a score (on a scale) per patient | Standard Error 0.03 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Contrast enhancement - Reader 1 | 1.00 mean of a score (on a scale) per patient | Standard Error 0.03 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Internal morphology - Reader 1 | 1.99 mean of a score (on a scale) per patient | Standard Error 0.02 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Contrast enhancement - Reader 2 | 1.00 mean of a score (on a scale) per patient | Standard Error 0.05 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Unenhanced MRI | Internal morphology - Reader 2 | 3.22 mean of a score (on a scale) per patient | Standard Error 0.05 |
Comparison: Criterion: Border delineation; Reader 1. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.p-value: <0.000195% CI: [1.46, 1.6]t-test, 2 sided
Comparison: Criterion: Border delineation; Reader 2. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.p-value: <0.000195% CI: [0.36, 0.58]t-test, 2 sided
Comparison: Criterion: Border delineation; Reader 3. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.p-value: <0.000195% CI: [1.65, 1.78]t-test, 2 sided
Comparison: Criterion: Internal morphology; Reader 1. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.p-value: <0.000195% CI: [1.76, 1.87]t-test, 2 sided
Comparison: Criterion: Internal morphology; Reader 2. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.p-value: <0.000195% CI: [0.42, 0.64]t-test, 2 sided
Comparison: Criterion: Internal morphology; Reader 3. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.p-value: <0.000195% CI: [1.95, 2.11]t-test, 2 sided
Comparison: Criterion: Contrast enhancement; Reader 1. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.p-value: <0.000195% CI: [2.56, 2.72]t-test, 2 sided
Comparison: Criterion: Contrast enhancement; Reader 2. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.p-value: <0.000195% CI: [1.68, 1.96]t-test, 2 sided
Comparison: Criterion: Contrast enhancement; Reader 3. The null hypothesis for primary objective was that the difference in mean scores between Paired images and Pre-contrast images for each of the 3 co-primary criteria was equal to 0. The Null hypothesis was rejected if the difference was significantly different from zero with a type 1 error set at 0.025. To conclude the superiority, the null hypothesis had to be rejected for all co-criteria simultaneously and for at least 2 out of 3 readers.p-value: <0.000195% CI: [2.26, 2.41]t-test, 2 sided
Secondary
Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI
The lesion visualization (per patient) was based on 3 co-primary criteria: border delineation, internal morphology and degree of contrast enhancement, assessed on the images performed with gadopiclenol and images performed with gadobutrol by 3 independent readers. The independent blinded reader recorded each of the 3 co-primary criteria for up to 3 most representative lesions, using a 4-point scale (1 = poor \[internal morphology\] or none \[border delineation, contrast enhancement\], 2 = moderate, 3 = good, 4 = excellent). The mean of scores for each patient and for each of the 3 lesion visualization co-criteria was calculated as follows: Mean of scores = score of lesion 1 + score of lesion 2 (if any) + score of lesion 3 (if any) divided by the number of lesions, ranged from 1 to 4. The difference in mean scores on matching lesions between gadopiclenol scores mean and gadobutrol scores mean was calculated for each of the 3 co-primary criteria and for each reader.
Time frame: At each of two MRI examinations with an interval of 2-14 days between two MRI examinations
Population: Per-Protocol Set (PPS) analysis including 260 patients (135 patients in the Arm 1 and 125 patients in the Arm 2) with no major protocol deviation who have Paired (combined unenhanced and contrast-enhanced) images for both gadopiclenol and gadobutrol assessable for this secondary outcome mesure for at least one matching lesion for at least one off-site reader. The analysis was based on participants (per patient).
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Border delineation - Reader 1 | 3.82 mean of a score (on a scale) per patient | Standard Error 0.02 |
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Border delineation - Reader 2 | 3.56 mean of a score (on a scale) per patient | Standard Error 0.05 |
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Border delineation - Reader 3 | 3.53 mean of a score (on a scale) per patient | Standard Error 0.03 |
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Internal morphology - Reader 2 | 3.75 mean of a score (on a scale) per patient | Standard Error 0.04 |
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Internal morphology - Reader 3 | 3.74 mean of a score (on a scale) per patient | Standard Error 0.03 |
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Contrast enhancement - Reader 1 | 3.69 mean of a score (on a scale) per patient | Standard Error 0.04 |
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Contrast enhancement - Reader 2 | 2.88 mean of a score (on a scale) per patient | Standard Error 0.07 |
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Contrast enhancement - Reader 3 | 3.35 mean of a score (on a scale) per patient | Standard Error 0.04 |
| Patients With Gadopiclenol Paired Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Internal morphology - Reader 1 | 3.83 mean of a score (on a scale) per patient | Standard Error 0.02 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Internal morphology - Reader 3 | 3.77 mean of a score (on a scale) per patient | Standard Error 0.03 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Border delineation - Reader 1 | 3.81 mean of a score (on a scale) per patient | Standard Error 0.02 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Border delineation - Reader 2 | 3.53 mean of a score (on a scale) per patient | Standard Error 0.05 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Contrast enhancement - Reader 1 | 3.68 mean of a score (on a scale) per patient | Standard Error 0.04 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Border delineation - Reader 3 | 3.57 mean of a score (on a scale) per patient | Standard Error 0.03 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Internal morphology - Reader 1 | 3.83 mean of a score (on a scale) per patient | Standard Error 0.02 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Contrast enhancement - Reader 3 | 3.37 mean of a score (on a scale) per patient | Standard Error 0.04 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Internal morphology - Reader 2 | 3.75 mean of a score (on a scale) per patient | Standard Error 0.04 |
| Patients With Gadopiclenol Pre Images | Lesion Visualization Comparing Gadopiclenol-enhanced MRI to Gadobutrol-enhanced MRI | Contrast enhancement - Reader 2 | 2.86 mean of a score (on a scale) per patient | Standard Error 0.07 |
Comparison: Criterion: Border delineation; Reader 1. The null hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 primary criteria was equal to the non inferiority margin (-0.35). The alternative hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 co-primary criteria was greater than the non inferiority margin.p-value: <0.000195% CI: [-0.05, 0.05]t-test, 2 sided
Comparison: Criterion: Border delineation; Reader 2. The null hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 primary criteria was equal to the non inferiority margin (-0.35). The alternative hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 co-primary criteria was greater than the non inferiority margin.p-value: <0.000195% CI: [-0.05, 0.1]t-test, 2 sided
Comparison: Criterion: Border delineation; Reader 3. The null hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 primary criteria was equal to the non inferiority margin (-0.35). The alternative hypothesis was that the difference in mean scores between gadopiclenol and gadobutrol for each of the 3 co-primary criteria was greater than the non inferiority margin.p-value: <0.000195% CI: [-0.1, 0.01]t-test, 2 sided
Comparison: Criterion: Internal morphology; Reader 1p-value: <0.000195% CI: [-0.06, 0.05]t-test, 2 sided
Comparison: Criterion: Internal morphology; Reader 2p-value: <0.000195% CI: [-0.07, 0.07]t-test, 2 sided
Comparison: Criterion: Internal morphology; Reader 3p-value: <0.000195% CI: [-0.08, 0.02]t-test, 2 sided
Comparison: Criterion: Contrast enhancement; Reader 1p-value: <0.000195% CI: [-0.06, 0.09]t-test, 2 sided
Comparison: Criterion: Contrast enhancement; Reader 2p-value: <0.000195% CI: [-0.07, 0.12]t-test, 2 sided
Comparison: Criterion: Contrast enhancement; Reader 3p-value: <0.000195% CI: [-0.08, 0.04]t-test, 2 sided