Trial Outcomes & Findings for A Randomized, Controlled Trial to Evaluate CT Image Quality Lumentin® 44 (NCT NCT03326518)
NCT ID: NCT03326518
Last Updated: 2020-10-27
Results Overview
difference in contrast density between lumen and wall (mucosal lining)
TERMINATED
PHASE2
45 participants
Day 1
2020-10-27
Participant Flow
Participant milestones
| Measure |
Lumentin® 44
Contrast agent
Lumentin® 44: Contrast agent
|
Diluted Omnipaque®
Contrast agent
Diluted Omnipaque®: Contrast agent
|
Movprep®
Contrast agent
Movprep®: Contrast agent
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
12
|
14
|
|
Overall Study
COMPLETED
|
16
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
Reasons for withdrawal
| Measure |
Lumentin® 44
Contrast agent
Lumentin® 44: Contrast agent
|
Diluted Omnipaque®
Contrast agent
Diluted Omnipaque®: Contrast agent
|
Movprep®
Contrast agent
Movprep®: Contrast agent
|
|---|---|---|---|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Lumentin® 44
n=19 Participants
Contrast agent
Lumentin® 44: Contrast agent
|
Diluted Omnipaque®
n=12 Participants
Contrast agent
Diluted Omnipaque®: Contrast agent
|
Movprep®
n=14 Participants
Contrast agent
Movprep®: Contrast agent
|
Total
n=45 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=19 Participants
|
0 Participants
n=12 Participants
|
0 Participants
n=14 Participants
|
0 Participants
n=45 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=19 Participants
|
5 Participants
n=12 Participants
|
8 Participants
n=14 Participants
|
19 Participants
n=45 Participants
|
|
Age, Categorical
>=65 years
|
13 Participants
n=19 Participants
|
7 Participants
n=12 Participants
|
6 Participants
n=14 Participants
|
26 Participants
n=45 Participants
|
|
Age, Customized
18-64 years
|
6 Participants
n=19 Participants
|
5 Participants
n=12 Participants
|
8 Participants
n=14 Participants
|
19 Participants
n=45 Participants
|
|
Age, Customized
65-84 years
|
13 Participants
n=19 Participants
|
6 Participants
n=12 Participants
|
6 Participants
n=14 Participants
|
25 Participants
n=45 Participants
|
|
Age, Customized
85 years and over
|
0 Participants
n=19 Participants
|
1 Participants
n=12 Participants
|
0 Participants
n=14 Participants
|
1 Participants
n=45 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=19 Participants
|
8 Participants
n=12 Participants
|
8 Participants
n=14 Participants
|
27 Participants
n=45 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=19 Participants
|
4 Participants
n=12 Participants
|
6 Participants
n=14 Participants
|
18 Participants
n=45 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Sweden
|
19 participants
n=19 Participants
|
12 participants
n=12 Participants
|
14 participants
n=14 Participants
|
45 participants
n=45 Participants
|
PRIMARY outcome
Timeframe: Day 1Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
difference in contrast density between lumen and wall (mucosal lining)
Outcome measures
| Measure |
Lumentin® 44
n=17 Participants
Contrast agent
Lumentin® 44: Contrast agent
|
Diluted Omnipaque®
n=12 Participants
Contrast agent
Diluted Omnipaque®: Contrast agent
|
Movprep®
n=14 Participants
Contrast agent
Movprep®: Contrast agent
|
|---|---|---|---|
|
Relative Mean Difference in Contrast Density
|
484.0 Hounsfield units
Standard Deviation 192.4
|
122.1 Hounsfield units
Standard Deviation 81.4
|
64.5 Hounsfield units
Standard Deviation 15.9
|
SECONDARY outcome
Timeframe: Day 1Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
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.
Outcome measures
| Measure |
Lumentin® 44
n=17 Participants
Contrast agent
Lumentin® 44: Contrast agent
|
Diluted Omnipaque®
n=12 Participants
Contrast agent
Diluted Omnipaque®: Contrast agent
|
Movprep®
n=14 Participants
Contrast agent
Movprep®: Contrast agent
|
|---|---|---|---|
|
Bowel Filling Properties, Extension
|
63.0 Likert Scale score
Standard Deviation 21.7
|
61.2 Likert Scale score
Standard Deviation 15.9
|
71.8 Likert Scale score
Standard Deviation 10.6
|
SECONDARY outcome
Timeframe: Day 1Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
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.
Outcome measures
| Measure |
Lumentin® 44
n=17 Participants
Contrast agent
Lumentin® 44: Contrast agent
|
Diluted Omnipaque®
n=12 Participants
Contrast agent
Diluted Omnipaque®: Contrast agent
|
Movprep®
n=14 Participants
Contrast agent
Movprep®: Contrast agent
|
|---|---|---|---|
|
Bowel Filling Properties, Distension
|
48.1 Likert Scale score
Standard Deviation 18.1
|
47.0 Likert Scale score
Standard Deviation 12.2
|
54.7 Likert Scale score
Standard Deviation 8.6
|
SECONDARY outcome
Timeframe: Day 1Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
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.
Outcome measures
| Measure |
Lumentin® 44
n=17 Participants
Contrast agent
Lumentin® 44: Contrast agent
|
Diluted Omnipaque®
n=12 Participants
Contrast agent
Diluted Omnipaque®: Contrast agent
|
Movprep®
n=14 Participants
Contrast agent
Movprep®: Contrast agent
|
|---|---|---|---|
|
Diagnostic Ability When Examining Abdominal CT
|
43.1 Likert Scale score
Standard Deviation 4.8
|
39.9 Likert Scale score
Standard Deviation 5.9
|
41.4 Likert Scale score
Standard Deviation 4.4
|
SECONDARY outcome
Timeframe: Day 1Population: 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.
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.
Outcome measures
| Measure |
Lumentin® 44
n=17 Participants
Contrast agent
Lumentin® 44: Contrast agent
|
Diluted Omnipaque®
Contrast agent
Diluted Omnipaque®: Contrast agent
|
Movprep®
Contrast agent
Movprep®: Contrast agent
|
|---|---|---|---|
|
Degradation of Contrast Agent (Lumentin® 44)
|
0.647 Scores on a scale (0-10)
Standard Deviation 0.996
|
—
|
—
|
SECONDARY outcome
Timeframe: Day 1Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive
Outcome measures
| Measure |
Lumentin® 44
n=17 Participants
Contrast agent
Lumentin® 44: Contrast agent
|
Diluted Omnipaque®
n=12 Participants
Contrast agent
Diluted Omnipaque®: Contrast agent
|
Movprep®
n=14 Participants
Contrast agent
Movprep®: Contrast agent
|
|---|---|---|---|
|
Subjects' Assessment of Taste of the Contrast Agent
|
4.0 Score (1-5)
Interval 3.0 to 5.0
|
4.0 Score (1-5)
Interval 3.0 to 5.0
|
2.5 Score (1-5)
Interval 1.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 1Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive
Outcome measures
| Measure |
Lumentin® 44
n=17 Participants
Contrast agent
Lumentin® 44: Contrast agent
|
Diluted Omnipaque®
n=12 Participants
Contrast agent
Diluted Omnipaque®: Contrast agent
|
Movprep®
n=14 Participants
Contrast agent
Movprep®: Contrast agent
|
|---|---|---|---|
|
Subjects' Assessment of Smell of the Contrast Agent
|
4.0 Score (1-5)
Interval 3.0 to 5.0
|
4.0 Score (1-5)
Interval 3.0 to 5.0
|
3.0 Score (1-5)
Interval 2.0 to 5.0
|
SECONDARY outcome
Timeframe: Day 1Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive
Outcome measures
| Measure |
Lumentin® 44
n=17 Participants
Contrast agent
Lumentin® 44: Contrast agent
|
Diluted Omnipaque®
n=12 Participants
Contrast agent
Diluted Omnipaque®: Contrast agent
|
Movprep®
n=14 Participants
Contrast agent
Movprep®: Contrast agent
|
|---|---|---|---|
|
Subjects' Assessment of Consistency of the Contrast Agent
|
3.0 Score (1-5
Interval 2.0 to 4.0
|
4.0 Score (1-5
Interval 3.0 to 5.0
|
3.0 Score (1-5
Interval 2.0 to 4.0
|
SECONDARY outcome
Timeframe: Day 1Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive
Outcome measures
| Measure |
Lumentin® 44
n=17 Participants
Contrast agent
Lumentin® 44: Contrast agent
|
Diluted Omnipaque®
n=12 Participants
Contrast agent
Diluted Omnipaque®: Contrast agent
|
Movprep®
n=14 Participants
Contrast agent
Movprep®: Contrast agent
|
|---|---|---|---|
|
Subjects' Assessment of Ability to Swallow the Contrast Agent
|
3.0 Score (1-5)
Interval 2.0 to 4.0
|
5.0 Score (1-5)
Interval 2.0 to 5.0
|
3.0 Score (1-5)
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: Day 1Population: Two patients in the Lumentin group withdrew prior to contrast agent intake and were withdrawn from the efficacy analysis.
The subjects assessed taste on a five degree-scale: 1. Very negative 2. Negative 3. Neutral 4. Positive 5. Very positive
Outcome measures
| Measure |
Lumentin® 44
n=17 Participants
Contrast agent
Lumentin® 44: Contrast agent
|
Diluted Omnipaque®
n=12 Participants
Contrast agent
Diluted Omnipaque®: Contrast agent
|
Movprep®
n=14 Participants
Contrast agent
Movprep®: Contrast agent
|
|---|---|---|---|
|
Subjects' Assessment of Fullness After Drinking the Contrast Agent
|
2.0 Score (1-5)
Interval 1.0 to 4.0
|
3.0 Score (1-5)
Interval 2.0 to 4.0
|
3.0 Score (1-5)
Interval 1.0 to 5.0
|
Adverse Events
Lumentin® 44
Diluted Omnipaque®
Movprep®
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Lumentin® 44
n=18 participants at risk
Contrast agent
Lumentin® 44: Contrast agent
|
Diluted Omnipaque®
n=12 participants at risk
Contrast agent
Diluted Omnipaque®: Contrast agent
|
Movprep®
n=14 participants at risk
Contrast agent
Movprep®: Contrast agent
|
|---|---|---|---|
|
General disorders
Chills
|
0.00%
0/18 • 1 day
|
8.3%
1/12 • Number of events 1 • 1 day
|
0.00%
0/14 • 1 day
|
|
Gastrointestinal disorders
Abdominal distension
|
5.6%
1/18 • Number of events 1 • 1 day
|
8.3%
1/12 • Number of events 1 • 1 day
|
7.1%
1/14 • Number of events 1 • 1 day
|
|
Gastrointestinal disorders
Abdominal pain upper
|
5.6%
1/18 • Number of events 1 • 1 day
|
25.0%
3/12 • Number of events 3 • 1 day
|
21.4%
3/14 • Number of events 3 • 1 day
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • 1 day
|
25.0%
3/12 • Number of events 3 • 1 day
|
42.9%
6/14 • Number of events 6 • 1 day
|
|
Gastrointestinal disorders
Eructation
|
5.6%
1/18 • Number of events 1 • 1 day
|
0.00%
0/12 • 1 day
|
0.00%
0/14 • 1 day
|
|
Gastrointestinal disorders
Flatulence
|
22.2%
4/18 • Number of events 4 • 1 day
|
33.3%
4/12 • Number of events 4 • 1 day
|
21.4%
3/14 • Number of events 3 • 1 day
|
|
Gastrointestinal disorders
Nausea
|
11.1%
2/18 • Number of events 2 • 1 day
|
16.7%
2/12 • Number of events 2 • 1 day
|
7.1%
1/14 • Number of events 1 • 1 day
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
5.6%
1/18 • Number of events 1 • 1 day
|
0.00%
0/12 • 1 day
|
0.00%
0/14 • 1 day
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place