Clinical Trial Results:
An open, randomized, controlled, single centre trial to evaluate CT image quality and diagnostic feasibility of Lumentin® 44, a new egg albumen based oral bowel filling agent, in comparison with diluted Omnipaque® and Movprep®, two commonly used agents in subjects referred for abdominal CT-examination.
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Summary
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EudraCT number |
2017-002368-42 |
Trial protocol |
SE |
Global end of trial date |
14 Feb 2019
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Results information
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Results version number |
v1 |
This version publication date |
20 Mar 2020
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First version publication date |
20 Mar 2020
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Other versions |
v2 |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
LUM-001
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT03326518 | ||
WHO universal trial number (UTN) |
- | ||
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Sponsors
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Sponsor organisation name |
Lument AB
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Sponsor organisation address |
Scheelevägen 22, LUND, Sweden, 223 63
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Public contact |
CEO, Lument AB, olof.book@lumentab.com
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Scientific contact |
CEO, Lument AB, olof.book@lumentab.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
02 Mar 2020
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
14 Feb 2019
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Global end of trial reached? |
Yes
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Global end of trial date |
14 Feb 2019
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
To compare the mean difference in contrast density shown on abdominal CT-images when using the contrast agent Lumentin® 44, with abdominal CT-images using diluted Omnipaque® and with abdominal CT-images using Movprep®
General information:
This was an open, randomized, controlled, single centre Phase II trial of Lumentin® 44 in comparison with diluted Omnipaque® and Movprep® in subjects referred to CT-examination of the abdomen. Eligible subjects were randomized to Lumentin® 44 (Lumentin 44 Arm), diluted Omnipaque® (diluted Omnipaque Arm), or Movprep® (movprep Arm) in a 2:1:1 ratio.
Lumentin was given in volumes of 750 mL to 1200 mL and Omnipaque and Movprep were given according to the general praxis of care at the clinical site.
The difference in contrast density between lumen and wall (mucosal lining) in CT-images was measured in 9 locations of the small bowel: 2 locations in each of the duodenum, jejunum, proximal ileum and distal ileum and in 1 location in the terminal ileum
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Protection of trial subjects |
The trial was conducted in compliance with the protocol, the International Conference on Harmonisation (ICH) guidelines on good clinical practice (GCP), the applicable European Directives and local legal requirements, and the ethical principles of the latest revision of the Declaration of Helsinki as adopted by the World Medical Association.
All information containing personal data were handled in accordance with Swedish data protection legislation and with the EU Data Protection Directive (95/46/EC). In accordance with the legislation, the data does not identify any persons taking part in the trial.
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Background therapy |
No background therapy was given. | ||
Evidence for comparator |
The comparators, Omnipaque® and Movprep® used in the trial are both standard of care treatment, commonly used as contrast agents, in patients referred to abdominal CT-examinations. Abbreviations used: Abd-CT: Abdominal-CT AE: Adverse events CT: Computed tomography FA: Full analysis HU: Hounsfield units IMP: Investigational medical product ROI: Region of interest SAE: Serious adverse events vs.: versus | ||
Actual start date of recruitment |
28 Nov 2017
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Sweden: 45
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Worldwide total number of subjects |
45
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EEA total number of subjects |
45
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
19
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From 65 to 84 years |
25
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85 years and over |
1
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Recruitment
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Recruitment details |
Subjects referred for abdominal or thoracoabdominal CT-examination at the clinical site were informed of the trial by a letter added to the referral letter informing them on date and time for the CT-examination, and by advertising posters at referring clinics. Subjects who had received an invitation letter were contacted by phone. | ||||||||||||||||||||||||||||
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Pre-assignment
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Screening details |
Subjects who were interested in participating in the trial, were sent full subject information and were asked to read it before the CT-examination visit. | ||||||||||||||||||||||||||||
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Period 1
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Period 1 title |
Overall Trial Period (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||
Blinding implementation details |
Eligible subjects were to be randomized in a 2:1:1 ratio to Lumentin 44, Omnipaque or Movprep
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Arms
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Are arms mutually exclusive |
Yes
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Arm title
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Lumentin 44 | ||||||||||||||||||||||||||||
Arm description |
Before CT-examination, subjects received Lumentin 44 in volumes of 750 mL to 1200 mL, which should be taken orally within 1 hour. | ||||||||||||||||||||||||||||
Arm type |
Experimental | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Lumentin 44
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Oral liquid
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Routes of administration |
Oral use
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Dosage and administration details |
pg28
Lumentin 44 was provided as an aqueous dispersion, which was whipped to a foam at the clinical site. The foam contained 44% of air, which was the radiological key ingredient that caused the agent's contrast properties.
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Arm title
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Diluted Omnipaque | ||||||||||||||||||||||||||||
Arm description |
Before CT-examination, subjects received diluted Omnipaque in volumes according to standard of care praxis at the study site (target volume 1000 mL). The diluted Omnipaque should be taken orally within 1 hour. | ||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Diluted Omnipaque
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Solution for injection
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Routes of administration |
Oral use
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Dosage and administration details |
Before oral administration, 30 mL of Omnipaque 240 mg I/mL was mixed with 970 mL of water.
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Arm title
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Movprep | ||||||||||||||||||||||||||||
Arm description |
Before CT-examination, subjects received Movprep in volumes according to standard of care praxis at the study site (target volume 1000 mL). The Movprep solution should be taken orally within 1 hour. | ||||||||||||||||||||||||||||
Arm type |
Active comparator | ||||||||||||||||||||||||||||
Investigational medicinal product name |
Movprep
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Powder for oral solution
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Routes of administration |
Oral use
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Dosage and administration details |
Before oral administration, the Movprep dose Units A and B were dissolved in 1000 mL of water.
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Baseline characteristics reporting groups
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Reporting group title |
Lumentin 44
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Reporting group description |
Before CT-examination, subjects received Lumentin 44 in volumes of 750 mL to 1200 mL, which should be taken orally within 1 hour. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Diluted Omnipaque
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Reporting group description |
Before CT-examination, subjects received diluted Omnipaque in volumes according to standard of care praxis at the study site (target volume 1000 mL). The diluted Omnipaque should be taken orally within 1 hour. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Movprep
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Reporting group description |
Before CT-examination, subjects received Movprep in volumes according to standard of care praxis at the study site (target volume 1000 mL). The Movprep solution should be taken orally within 1 hour. | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Subject analysis sets
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Subject analysis set title |
Safety set
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Subject analysis set type |
Safety analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All subjects who drank at least some part of the stipulated dose of contrast agent (Lumentin 44, diluted Omnipaque, or Movprep) were included in the Safety Data Set of the trial. The subjects were included in the analysis according to the treatment actually received.
18 (94.7%) out of the 19 randomised subjects in Lumentin 44 group, 12 out of 12 (100%) of the randomised subjects in the Omnipaque group, and 14 out of 14 (100%) of the randomised subjects in the Movprep group were included in the Safety population.
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Subject analysis set title |
Full Analysis (FA) Set
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Subject analysis set type |
Full analysis | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Subject analysis set description |
All correctly included and randomised subjects who received at least some portion of the contrast agents (Lumentin 44, diluted Omnipaque, or Movprep) and for whom a CT-examination was performed. All subjects were included in the group according to the intention based on the randomisation.
17 (89.5%) out of the 19 randomised subjects in Lumentin 44 group, 12 out of 12 (100%) of the randomised subjects in the Omnipaque group, and 14 out of 14 (100%) of the randomised subjects in the Movprep group were included in the FA population.
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End points reporting groups
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Reporting group title |
Lumentin 44
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Reporting group description |
Before CT-examination, subjects received Lumentin 44 in volumes of 750 mL to 1200 mL, which should be taken orally within 1 hour. | ||
Reporting group title |
Diluted Omnipaque
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Reporting group description |
Before CT-examination, subjects received diluted Omnipaque in volumes according to standard of care praxis at the study site (target volume 1000 mL). The diluted Omnipaque should be taken orally within 1 hour. | ||
Reporting group title |
Movprep
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Reporting group description |
Before CT-examination, subjects received Movprep in volumes according to standard of care praxis at the study site (target volume 1000 mL). The Movprep solution should be taken orally within 1 hour. | ||
Subject analysis set title |
Safety set
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Subject analysis set type |
Safety analysis | ||
Subject analysis set description |
All subjects who drank at least some part of the stipulated dose of contrast agent (Lumentin 44, diluted Omnipaque, or Movprep) were included in the Safety Data Set of the trial. The subjects were included in the analysis according to the treatment actually received.
18 (94.7%) out of the 19 randomised subjects in Lumentin 44 group, 12 out of 12 (100%) of the randomised subjects in the Omnipaque group, and 14 out of 14 (100%) of the randomised subjects in the Movprep group were included in the Safety population.
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Subject analysis set title |
Full Analysis (FA) Set
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Subject analysis set type |
Full analysis | ||
Subject analysis set description |
All correctly included and randomised subjects who received at least some portion of the contrast agents (Lumentin 44, diluted Omnipaque, or Movprep) and for whom a CT-examination was performed. All subjects were included in the group according to the intention based on the randomisation.
17 (89.5%) out of the 19 randomised subjects in Lumentin 44 group, 12 out of 12 (100%) of the randomised subjects in the Omnipaque group, and 14 out of 14 (100%) of the randomised subjects in the Movprep group were included in the FA population.
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End point title |
Difference in Contrast Density | ||||||||||||||||
End point description |
The difference in contrast density was measured indepentently by 2 investigators in 2 locations in each of the 4 defined sub-segments: duodenum, jejunum, proximal ileum, and distal ileum, and in 1 location of the terminal ileum.
Regions of interest (ROI) measuring 6 mm in diameter were selected in the lumen of each location. The ROIs were placed where the lumen was best shown in the CT-image. The CT-scan software provided a mean HU measurement of each of the selected ROIs and the values were recorded by the Investigators.
The HU of the wall was set to +80HU as a standard for all measurements. It was not possible to discriminate between the lumen and the wall for Movprep and Diluted Omnipaque as they have a contrast similar to the wall contrast.
The difference in contrast density between bowel lumen and wall were calculated by subtracting the pinpoint HU value(s) of the wall (+80HU) from the mean ROI HU value(s) of the lumen, and the absolute value was presented.
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End point type |
Primary
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End point timeframe |
CT-examination, Day 1
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Statistical analysis title |
Wilcoxon rank sum test | ||||||||||||||||
Statistical analysis description |
The null-hypothesis that the primary efficacy variable is equal in the groups was tested by means of the Wilcoxon rank sum test. In each of these analyses a 2-sided p-value less than 5% was considered statistically significant.
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Comparison groups |
Lumentin 44 v Diluted Omnipaque v Movprep
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Number of subjects included in analysis |
43
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
P-value |
< 0.0001 [1] | ||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||
Confidence interval |
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| Notes [1] - Analysis of Lumentin 44 vs. diluted Omnipaque: P-value <0.0001 Analysis of Lumentin 44 vs. Movprep: P-value <0.0001 |
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End point title |
Bowel Filling Properties, Extension | ||||||||||||||||
End point description |
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 Extension score is the sum of the grades both assessors and in each sub-segment and hence range from 10 to 90.
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End point type |
Secondary
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End point timeframe |
CT-examination, Day 1
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Statistical analysis title |
Wilcoxon rank sum test | ||||||||||||||||
Statistical analysis description |
The null-hypothesis that the primary efficacy variable is equal in the groups was tested by means of the
Wilcoxon rank sum test. In each of these analyses a 2-sided p-value less than 5% was considered
statistically significant.
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Comparison groups |
Lumentin 44 v Diluted Omnipaque v Movprep
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Number of subjects included in analysis |
43
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
P-value |
= 0.7229 [2] | ||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||
Confidence interval |
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| Notes [2] - Analysis of Lumentin 44 vs. diluted Omnipaque: P-value =0.7229 Analysis of Lumentin 44 vs. Movprep: P-value =0.4624 |
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End point title |
Bowel filling properties, Distension | ||||||||||||||||
End point description |
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 Distension score is the sum of the grades both assessors and in each sub-segment and range from 10 to 90.
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End point type |
Secondary
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End point timeframe |
CT-examination, Day 1
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Statistical analysis title |
Wilcoxon rank sum test | ||||||||||||||||
Statistical analysis description |
The null-hypothesis that the primary efficacy variable is equal in the groups was tested by means of the
Wilcoxon rank sum test. In each of these analyses a 2-sided p-value less than 5% was considered
statistically significant.
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Comparison groups |
Lumentin 44 v Diluted Omnipaque v Movprep
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Number of subjects included in analysis |
43
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
P-value |
= 1 [3] | ||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||
Confidence interval |
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| Notes [3] - Analysis of Lumentin 44 vs. diluted Omnipaque: P-value =1.0000 Analysis of Lumentin 44 vs. Movprep: P-value =0.3208 |
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End point title |
Diagnostic Ability when Examining Abdominal CT | ||||||||||||||||
End point description |
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 Diagnostic ability score was the sum of the scores from both assessors and ranged from 6 to 54.
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End point type |
Secondary
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End point timeframe |
CT-examination, Day 1
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Statistical analysis title |
Wilcoxon rank sum test | ||||||||||||||||
Statistical analysis description |
The null-hypothesis that the primary efficacy variable is equal in the groups was tested by means of the
Wilcoxon rank sum test. In each of these analyses a 2-sided p-value less than 5% was considered
statistically significant.
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Comparison groups |
Lumentin 44 v Diluted Omnipaque v Movprep
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Number of subjects included in analysis |
43
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Analysis specification |
Pre-specified
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Analysis type |
equivalence | ||||||||||||||||
P-value |
= 0.1755 [4] | ||||||||||||||||
Method |
Wilcoxon (Mann-Whitney) | ||||||||||||||||
Confidence interval |
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| Notes [4] - Analysis of Lumentin 44 vs. diluted Omnipaque: P-value =0.1755 Analysis of Lumentin 44 vs. Movprep: P-value =0.3284 |
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End point title |
Degradation of Contrast Agent (Lumentin® 44) [5] | ||||||||
End point description |
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 from both assessors and in each sub-segment and range from 0 to 20.
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End point type |
Secondary
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End point timeframe |
CT-Examination, Day 1
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| Notes [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period. Justification: Lumentin 44 is a foam containing air, and it could be suspected that the air bubbles would not withstand the condition in the stomach or the 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. |
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End point title |
Subjects' Assessment of Taste of the Contrast Agent | ||||||||||||||||
End point description |
The subjects assessed taste on a five degree-scale:
1. Very negative
2. Negative
3. Neutral
4. Positive
5. Very positive
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End point type |
Secondary
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End point timeframe |
Day 1
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Subjects' Assessment of Smell of the Contrast Agent | ||||||||||||||||
End point description |
The subjects assessed smell on a five degree-scale:
1. Very negative
2. Negative
3. Neutral
4. Positive
5. Very positive
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End point type |
Secondary
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End point timeframe |
Day 1
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Subjects' Assessment of Consistency of the Contrast Agent | ||||||||||||||||
End point description |
The subjects assessed consistency on a five degree-scale:
1. Very negative
2. Negative
3. Neutral
4. Positive
5. Very positive
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End point type |
Secondary
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End point timeframe |
Day 1
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Subjects' Assessment of Ability to Swallow the Contrast Agent | ||||||||||||||||
End point description |
The subjects assessed ability to swallow on a five degree-scale:
1. Very difficult
2. Difficult
3. Medium
4. Easy
5. Very easy
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End point type |
Secondary
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End point timeframe |
Day 1
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| No statistical analyses for this end point | |||||||||||||||||
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End point title |
Subjects' Assessment of Fullness after Drinking the Contrast Agent | ||||||||||||||||
End point description |
The subjects assessed fullness on a five degree-scale:
1. Very full
2. Full
3. Medium full
4. Barely full
5. Not at all full.
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End point type |
Secondary
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End point timeframe |
Day 1
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| No statistical analyses for this end point | |||||||||||||||||
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Adverse events information
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Timeframe for reporting adverse events |
AEs were reported from start of intake of the study drug and until a telephone interview, taking place 12–48 hours after the CT-examination.
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Adverse event reporting additional description |
AEs were collected using non-leading questions, observed, or spontaneously volunteered by subjects.
Especially solicited AEs were: Stomach ache, Burping, Letting of wind, Nausea, Sensation of fullness. Solicited AEs and abnormal clinical significant laboratory values were also to be included in "all AEs".
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
19.0
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Reporting groups
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Reporting group title |
Lumentin 44
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Reporting group description |
Before CT-scan, subjects received Lumentin 44 in volumes of 750 mL to 1200 mL, which should be taken within 1 hour. All AEs reported (including solicited AEs) are presented. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Diluted Omnipaque
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Reporting group description |
Before CT-scan, subjects received Omnipaque in volumes according to standard of care (target volume 1000 mL), which should be taken within 1 hour. All AEs reported (including solicited AEs) are presented. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Reporting group title |
Movprep
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Reporting group description |
Before CT-scan, subjects received Movprep in volumes according to standard of care (target volume 1000 mL), which should be taken within 1 hour. All AEs reported (including solicited AEs) are presented. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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| Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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| Were there any global substantial amendments to the protocol? Yes | |||
Date |
Amendment |
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11 Nov 2017 |
Amendment No. 1 was implemented before start of enrollment.
• The minimum volumes of diluted Omnipaque and Movprep required to be taken by the subject were adjusted to comply with the general praxis of care at the Department of Imaging and Function, Skåne University Hospital.
• The dose for the intravenous contrast agent, Omnipaque® 350 mg I/mL, which in error was stated as 60 to 90 mL, was corrected to the dose range according to the standard procedure: 60 to 115 mL.
• The exclusion criterion, prohibiting the inclusion of subjects participating in other clinical studies, was revised to allow participating in an oncology clinical trial if the subject was in the follow-up phase of the trial or had been on reduced maintenance treatment for at least the last 6 weeks.
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05 Jul 2018 |
• The assessment of the primary objective in the trial was changed to directly measure the mean difference in contrast density between the lumen and the wall of the intestine instead of relating it to the contrast density of the stomach. The reason for the change was that the main objective of the trial was to show differences between the 3 contrast agents. The patients came to the CT-examination fasted which led to that the density of the stomach was on par with the bowel. The difference between the contrast agents might therefore be obscured by relating the contrast density within patients to the contrast density of the stomach.
• The total number of subjects to be recruited was lowered from 114 to 80 evaluable subjects. The number of subjects in the Lumentin 44 arm would be 40 and in the 2 comparator arms the numbers were set to 20. Because of this change, the power of the trial was lowered from 90% to 78% (with a maintained 2-sided p-value less than 0.0500) in the previous version of the protocol.
• To facilitate recruitment, posters were placed at the oncology departments at Skåne University Hospital and invitation letters were handed out to those interested.
• The inclusion criteria were changed so fasting for 4 hours was required before intake of contrast agent for patients coming for CT-examination. This change was made to ensure that the contrast agents reached the terminal sections of the bowel.
• For diluted Omnipaque, one of the standard oral contrast agents, the addition of 30 mL 70% Sorbitol was omitted. The reason was that some patients were reluctant to take this contrast agent due to undesirable side effects of the Sorbitol additive. General praxis of care at the Department of Imaging and Function, Skåne University Hospital, includes dilution of Omnipaque both with and without Sorbitol addition. Omission of Sorbitol in this trial was therefore not considered to have any negative effect on neither subject safety nor evaluation of the trial. |
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Interruptions (globally) |
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| Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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| Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
| None reported | |||
