Subjects Referred to CT-examination of the Abdomen
Conditions
Brief summary
Subjects referred for abdominal or thoracoabdominal CT-examination will be randomised to either the three contrast agents Lumentin® 44, Omnipaque® or Movprep. The difference in contrast density, as observed in the CT-examination, between lumen and wall (mucosal lining) will be compared by the three contrast agents.
Interventions
DIAGNOSTIC_TESTLumentin® 44
Contrast agent
DIAGNOSTIC_TESTDiluted Omnipaque®
Contrast agent
DIAGNOSTIC_TESTMovprep®
Contrast agent
Sponsors
Lument AB
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects of either gender at least 18 years at the time of signing the informed consent. * Having a clinical indication for CT-examination of the abdomen
Exclusion criteria
* IV administration of iodine is contraindicated * Known allergy to egg albumen * Clinical suspicion, according to medical record, of fistula formation and/or leakage * Referral indication of small bowel disease(s) * Having known manifest thyrotoxicosis * Having known phenylketonuria * Having known Glucose-6-phosphatase deficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Relative Mean Difference in Contrast Density | Day 1 | difference in contrast density between lumen and wall (mucosal lining) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Bowel Filling Properties, Distension | Day 1 | The bowel filling agent caused a local widening of the bowel loop, distension. The filling of each of the 5 selected sub-segments of the small bowel in terms of distension was examined on the CT-scan by both the 2 investigators independently of each other, and graded using Likert scales between 1 and 9. Distension scale: 1. No identifiable contrast agent 2. A minimal amount of contrast agent is identified 3. Small amount of contrast agent, insufficient for placing a ROI of 6 mm 4. Amount of contrast agent just allowing for a ROI of 6 mm 5. Medium filled bowel loop 6. Slightly better than grade 5 7. Good filling 8. Optimal filling 9. Excellent or almost over distended The evaluation was made by 2 independent radiology experts. The Distension score is the sum of the grades in each sub-segment from both evaluations and hence range from 10 to 90. |
| Diagnostic Ability When Examining Abdominal CT | Day 1 | Diagnostic ability when examining Abd-CT was assessed on the CT-scan by the 2 investigators independently of each other. The following features were assessed: * Small bowel appearance * Parenchymal organs, i.e. Pancreas, ovaries, urinary bladder * Mesenterium and omentum using a Likert scales of 1-9 ranging, where: 1.Impossible to observe details 5\. Medium 9\. Excellent resolution The evaluation was made by 2 independent radiology experts. The Diagnostic ability score is the sum of the scores of each feature from both evaluations and hence range from 6 to 54. |
| Degradation of Contrast Agent (Lumentin® 44) | Day 1 | Degradation of Lumentin 44 was founded on the 2 characteristics; coalescence and syneresis or drainage. Coalescence: 0\. No bubbles visually detectable at the CT-scan 1\. Bubbles visually detectable at the CT-scan Syneresis or drainage: 0\. No syneresis or drainage, i.e. separation of air and liquid phases, observed 1\. Syneresis or drainage observed Signs of degradation were assessed on the CT-scan, by both Investigator and Sub-Investigator, independently of each other, in each of the 5 selected sub-segments of the small bowel. The degradation of contrast agents score is the sum of the scores in each sub-segment and range from 0 to 10. |
| Subjects' Assessment of Taste of the Contrast Agent | Day 1 | The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive |
| Bowel Filling Properties, Extension | Day 1 | The bowel filling agent was distributed along the length of small bowel, i.e. the extension. The filling of each of the 5 selected sub-segments of the small bowel in terms of extension was examined on the CT-scan by 2 investigators, independently of each other, and graded using Likert scales between 1 and 9. Extension scale: 1. No sign of contrast agent 2. Trace of contrast agent filling 3. Segment filled to ca. 25% 4. Segment filled to \>25% but \<50% 5. Filled to segment filled to 50% 6. Segment filled \> 50% but \<75% 7. Segment filled to ca. 75% 8. Segment filled to \>75% but \<100% 9. Segment filled to 100% The evaluation was made by 2 independent radiology experts. The Extension score is the sum of the grades in each sub-segment from both evaluations and hence range from 10 to 90. |
| Subjects' Assessment of Consistency of the Contrast Agent | Day 1 | The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive |
| Subjects' Assessment of Ability to Swallow the Contrast Agent | Day 1 | The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive |
| Subjects' Assessment of Fullness After Drinking the Contrast Agent | Day 1 | The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive |
| Subjects' Assessment of Smell of the Contrast Agent | Day 1 | The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Lumentin® 44 Contrast agent
Lumentin® 44: Contrast agent | 19 |
| Diluted Omnipaque® Contrast agent
Diluted Omnipaque®: Contrast agent | 12 |
| Movprep® Contrast agent
Movprep®: Contrast agent | 14 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 0 | 1 |
| Overall Study | Protocol Violation | 1 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 | 0 |
Baseline characteristics
| Characteristic | Diluted Omnipaque® | Movprep® | Lumentin® 44 | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 7 Participants | 6 Participants | 13 Participants | 26 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 8 Participants | 6 Participants | 19 Participants |
| Age, Customized 18-64 years | 5 Participants | 8 Participants | 6 Participants | 19 Participants |
| Age, Customized 65-84 years | 6 Participants | 6 Participants | 13 Participants | 25 Participants |
| Age, Customized 85 years and over | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants |
| Region of Enrollment Sweden | 12 participants | 14 participants | 19 participants | 45 participants |
| Sex: Female, Male Female | 8 Participants | 8 Participants | 11 Participants | 27 Participants |
| Sex: Female, Male Male | 4 Participants | 6 Participants | 8 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 12 | 0 / 14 |
| other Total, other adverse events | 7 / 18 | 7 / 12 | 8 / 14 |
| serious Total, serious adverse events | 0 / 18 | 0 / 12 | 0 / 14 |
Outcome results
Primary
Relative Mean Difference in Contrast Density
difference in contrast density between lumen and wall (mucosal lining)
Time frame: Day 1
Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumentin® 44 | Relative Mean Difference in Contrast Density | 484.0 Hounsfield units | Standard Deviation 192.4 |
| Diluted Omnipaque® | Relative Mean Difference in Contrast Density | 122.1 Hounsfield units | Standard Deviation 81.4 |
| Movprep® | Relative Mean Difference in Contrast Density | 64.5 Hounsfield units | Standard Deviation 15.9 |
Secondary
Bowel Filling Properties, Distension
The bowel filling agent caused a local widening of the bowel loop, distension. The filling of each of the 5 selected sub-segments of the small bowel in terms of distension was examined on the CT-scan by both the 2 investigators independently of each other, and graded using Likert scales between 1 and 9. Distension scale: 1. No identifiable contrast agent 2. A minimal amount of contrast agent is identified 3. Small amount of contrast agent, insufficient for placing a ROI of 6 mm 4. Amount of contrast agent just allowing for a ROI of 6 mm 5. Medium filled bowel loop 6. Slightly better than grade 5 7. Good filling 8. Optimal filling 9. Excellent or almost over distended The evaluation was made by 2 independent radiology experts. The Distension score is the sum of the grades in each sub-segment from both evaluations and hence range from 10 to 90.
Time frame: Day 1
Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumentin® 44 | Bowel Filling Properties, Distension | 48.1 Likert Scale score | Standard Deviation 18.1 |
| Diluted Omnipaque® | Bowel Filling Properties, Distension | 47.0 Likert Scale score | Standard Deviation 12.2 |
| Movprep® | Bowel Filling Properties, Distension | 54.7 Likert Scale score | Standard Deviation 8.6 |
Secondary
Bowel Filling Properties, Extension
The bowel filling agent was distributed along the length of small bowel, i.e. the extension. The filling of each of the 5 selected sub-segments of the small bowel in terms of extension was examined on the CT-scan by 2 investigators, independently of each other, and graded using Likert scales between 1 and 9. Extension scale: 1. No sign of contrast agent 2. Trace of contrast agent filling 3. Segment filled to ca. 25% 4. Segment filled to \>25% but \<50% 5. Filled to segment filled to 50% 6. Segment filled \> 50% but \<75% 7. Segment filled to ca. 75% 8. Segment filled to \>75% but \<100% 9. Segment filled to 100% The evaluation was made by 2 independent radiology experts. The Extension score is the sum of the grades in each sub-segment from both evaluations and hence range from 10 to 90.
Time frame: Day 1
Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumentin® 44 | Bowel Filling Properties, Extension | 63.0 Likert Scale score | Standard Deviation 21.7 |
| Diluted Omnipaque® | Bowel Filling Properties, Extension | 61.2 Likert Scale score | Standard Deviation 15.9 |
| Movprep® | Bowel Filling Properties, Extension | 71.8 Likert Scale score | Standard Deviation 10.6 |
Secondary
Degradation of Contrast Agent (Lumentin® 44)
Degradation of Lumentin 44 was founded on the 2 characteristics; coalescence and syneresis or drainage. Coalescence: 0\. No bubbles visually detectable at the CT-scan 1\. Bubbles visually detectable at the CT-scan Syneresis or drainage: 0\. No syneresis or drainage, i.e. separation of air and liquid phases, observed 1\. Syneresis or drainage observed Signs of degradation were assessed on the CT-scan, by both Investigator and Sub-Investigator, independently of each other, in each of the 5 selected sub-segments of the small bowel. The degradation of contrast agents score is the sum of the scores in each sub-segment and range from 0 to 10.
Time frame: Day 1
Population: Lumentin 44 is a foam containing air, and it could be suspected that the air bubbles would not withstand the condition in the stomach/intestines. Therefore, the end point Degradation of Contrast Agent was only valid for Lumentin 44 and it was included to prove the resisting power of Lumentin 44 and not to compare the IMP with Omnipaque or Movprep.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumentin® 44 | Degradation of Contrast Agent (Lumentin® 44) | 0.647 Scores on a scale (0-10) | Standard Deviation 0.996 |
Secondary
Diagnostic Ability When Examining Abdominal CT
Diagnostic ability when examining Abd-CT was assessed on the CT-scan by the 2 investigators independently of each other. The following features were assessed: * Small bowel appearance * Parenchymal organs, i.e. Pancreas, ovaries, urinary bladder * Mesenterium and omentum using a Likert scales of 1-9 ranging, where: 1.Impossible to observe details 5\. Medium 9\. Excellent resolution The evaluation was made by 2 independent radiology experts. The Diagnostic ability score is the sum of the scores of each feature from both evaluations and hence range from 6 to 54.
Time frame: Day 1
Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Lumentin® 44 | Diagnostic Ability When Examining Abdominal CT | 43.1 Likert Scale score | Standard Deviation 4.8 |
| Diluted Omnipaque® | Diagnostic Ability When Examining Abdominal CT | 39.9 Likert Scale score | Standard Deviation 5.9 |
| Movprep® | Diagnostic Ability When Examining Abdominal CT | 41.4 Likert Scale score | Standard Deviation 4.4 |
Secondary
Subjects' Assessment of Ability to Swallow the Contrast Agent
The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive
Time frame: Day 1
Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lumentin® 44 | Subjects' Assessment of Ability to Swallow the Contrast Agent | 3.0 Score (1-5) |
| Diluted Omnipaque® | Subjects' Assessment of Ability to Swallow the Contrast Agent | 5.0 Score (1-5) |
| Movprep® | Subjects' Assessment of Ability to Swallow the Contrast Agent | 3.0 Score (1-5) |
Secondary
Subjects' Assessment of Consistency of the Contrast Agent
The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive
Time frame: Day 1
Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lumentin® 44 | Subjects' Assessment of Consistency of the Contrast Agent | 3.0 Score (1-5 |
| Diluted Omnipaque® | Subjects' Assessment of Consistency of the Contrast Agent | 4.0 Score (1-5 |
| Movprep® | Subjects' Assessment of Consistency of the Contrast Agent | 3.0 Score (1-5 |
Secondary
Subjects' Assessment of Fullness After Drinking the Contrast Agent
The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive
Time frame: Day 1
Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lumentin® 44 | Subjects' Assessment of Fullness After Drinking the Contrast Agent | 2.0 Score (1-5) |
| Diluted Omnipaque® | Subjects' Assessment of Fullness After Drinking the Contrast Agent | 3.0 Score (1-5) |
| Movprep® | Subjects' Assessment of Fullness After Drinking the Contrast Agent | 3.0 Score (1-5) |
Secondary
Subjects' Assessment of Smell of the Contrast Agent
The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive
Time frame: Day 1
Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lumentin® 44 | Subjects' Assessment of Smell of the Contrast Agent | 4.0 Score (1-5) |
| Diluted Omnipaque® | Subjects' Assessment of Smell of the Contrast Agent | 4.0 Score (1-5) |
| Movprep® | Subjects' Assessment of Smell of the Contrast Agent | 3.0 Score (1-5) |
Secondary
Subjects' Assessment of Taste of the Contrast Agent
The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive
Time frame: Day 1
Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Lumentin® 44 | Subjects' Assessment of Taste of the Contrast Agent | 4.0 Score (1-5) |
| Diluted Omnipaque® | Subjects' Assessment of Taste of the Contrast Agent | 4.0 Score (1-5) |
| Movprep® | Subjects' Assessment of Taste of the Contrast Agent | 2.5 Score (1-5) |