Subjects Referred to CT-examination of the Abdomen Clinical Trial
Official title:
An Open, Randomized, Controlled, Single Centre Trial to Evaluate CT Image Quality and Diagnostic Feasibility of Lumentin® 44, in Comparison With Omnipaque and Movprep.
| Verified date | May 2020 |
| Source | Lument AB |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Terminated |
| Enrollment | 45 |
| Est. completion date | February 15, 2019 |
| Est. primary completion date | September 30, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Sweden | Department of medical imaging and function | Malmö |
| Lead Sponsor | Collaborator |
|---|---|
| Lument AB |
Sweden,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Relative Mean Difference in Contrast Density | difference in contrast density between lumen and wall (mucosal lining) | Day 1 | |
| 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: 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 | |
| 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: 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 | |
| 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. |
Day 1 | |
| 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. |
Day 1 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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 |