A Randomized, Controlled Trial to Evaluate CT Image Quality Lumentin® 44
- Conditions
- Subjects Referred to CT-examination of the Abdomen
- Interventions
- Diagnostic Test: Movprep®Diagnostic Test: Lumentin® 44Diagnostic Test: Diluted Omnipaque®
- Registration Number
- NCT03326518
- Lead Sponsor
- Lument AB
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 45
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Movprep® Movprep® Contrast agent Lumentin® 44 Lumentin® 44 Contrast agent Diluted Omnipaque® Diluted Omnipaque® Contrast agent
- Primary Outcome Measures
Name Time Method Relative Mean Difference in Contrast Density Day 1 difference in contrast density between lumen and wall (mucosal lining)
- Secondary Outcome Measures
Name Time Method 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.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.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.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 positiveDegradation 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 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 positiveSubjects' 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 positiveSubjects' 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 positiveSubjects' 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
Trial Locations
- Locations (1)
Department of medical imaging and function
🇸🇪Malmö, Sweden