NCT03326518 is a Phase 2 clinical trial of Lumentin® 44 in Subjects Referred to CT-examination of the Abdomen, sponsored by Lument AB.

Who is sponsoring NCT03326518?

NCT03326518 is sponsored by Lument AB.

What drugs are being tested in NCT03326518?

Interventions in NCT03326518: Lumentin® 44, Diluted Omnipaque®, Movprep®.

What condition does NCT03326518 study?

NCT03326518 studies Subjects Referred to CT-examination of the Abdomen.

Is NCT03326518 still recruiting?

NCT03326518 is currently terminated. Last updated 27 October 2020.

Are results published for NCT03326518?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-10-27 · How we verify

NCT03326518

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Terminated Phase 2 Results posted Last updated 27 October 2020

What this trial tests

Phase 2 trial testing Lumentin® 44 in Subjects Referred to CT-examination of the Abdomen in 45 participants. Terminated before completion.

Timeline

28 November 2017

Primary endpoint
30 September 2018

15 February 2019

Quick facts

Lead sponsor	Lument AB
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	45
Start date	28 November 2017
Primary completion	30 September 2018
Estimated completion	15 February 2019
Sites	1 location across Sweden

Drugs / interventions tested

Lumentin® 44
Diluted Omnipaque®
Movprep®

Conditions studied

Subjects Referred to CT-examination of the Abdomen — all drugs for Subjects Referred to CT-examination of the Abdomen →

Sponsor

Lument AB — full company profile →

Who can join

18 and older, any sex, with Subjects Referred to CT-examination of the Abdomen. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Relative Mean Difference in Contrast Density Primary · Day 1

difference in contrast density between lumen and wall (mucosal lining)

Group	Value	95% CI
Lumentin® 44	484.0	± 192.4
Diluted Omnipaque®	122.1	± 81.4
Movprep®	64.5	± 15.9

Bowel Filling Properties, Extension Secondary · 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. S

Group	Value	95% CI
Lumentin® 44	63.0	± 21.7
Diluted Omnipaque®	61.2	± 15.9
Movprep®	71.8	± 10.6

Bowel Filling Properties, Distension Secondary · 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 gra

Group	Value	95% CI
Lumentin® 44	48.1	± 18.1
Diluted Omnipaque®	47.0	± 12.2
Movprep®	54.7	± 8.6

Diagnostic Ability When Examining Abdominal CT Secondary · 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.

Group	Value	95% CI
Lumentin® 44	43.1	± 4.8
Diluted Omnipaque®	39.9	± 5.9
Movprep®	41.4	± 4.4

Degradation of Contrast Agent (Lumentin® 44) Secondary · 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

Group	Value	95% CI
Lumentin® 44	0.647	± 0.996

Subjects' Assessment of Taste of the Contrast Agent Secondary · Day 1