A Randomized, Controlled Trial to Evaluate CT Image Quality Lumentin® 44

Study Overview
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Brief Summary
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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.

Official Title
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An Open, Randomized, Controlled, Single Centre Trial to Evaluate CT Image Quality and Diagnostic Feasibility of Lumentin® 44, in Comparison With Omnipaque and Movprep.

Conditions
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Subjects Referred to CT-examination of the Abdomen

Intervention / Treatment
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* Diagnostic Test: Lumentin® 44
* Diagnostic Test: Diluted Omnipaque®
* Diagnostic Test: Movprep®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lumentin® 44<br>Contrast agent | Diagnostic Test: Lumentin® 44<br>* Contrast agent<br>|
| Active Comparator: Diluted Omnipaque®<br>Contrast agent | Diagnostic Test: Diluted Omnipaque®<br>* Contrast agent<br>|
| Active Comparator: Movprep®<br>Contrast agent | Diagnostic Test: Movprep®<br>* Contrast agent<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative Mean Difference in Contrast Density | difference in contrast density between lumen and wall (mucosal lining) | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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: No sign of contrast agent Trace of contrast agent filling Segment filled to ca. 25% Segment filled to >25% but <50% Filled to segment filled to 50% Segment filled > 50% but <75% Segment filled to ca. 75% Segment filled to >75% but <100% 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. | Day 1 | 
| 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: No identifiable contrast agent A minimal amount of contrast agent is identified Small amount of contrast agent, insufficient for placing a ROI of 6 mm Amount of contrast agent just allowing for a ROI of 6 mm Medium filled bowel loop Slightly better than grade 5 Good filling Optimal filling 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. | Day 1 | 
| 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. | Day 1 | 
| 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. | Day 1 | 
| Subjects' Assessment of Taste of the Contrast Agent | The subjects assessed taste on a five degree-scale: Very negative Negative Neutral Positive Very positive | Day 1 | 
| Subjects' Assessment of Smell of the Contrast Agent | The subjects assessed taste on a five degree-scale: Very negative Negative Neutral Positive Very positive | Day 1 | 
| Subjects' Assessment of Consistency of the Contrast Agent | The subjects assessed taste on a five degree-scale: Very negative Negative Neutral Positive Very positive | Day 1 | 
| Subjects' Assessment of Ability to Swallow the Contrast Agent | The subjects assessed taste on a five degree-scale: Very negative Negative Neutral Positive Very positive | Day 1 | 
| Subjects' Assessment of Fullness After Drinking the Contrast Agent | The subjects assessed taste on a five degree-scale: Very negative Negative Neutral Positive Very positive | Day 1 |