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

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

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.

Study Overview

• Status: Terminated
• Conditions: Subjects Referred to CT-examination of the Abdomen
• Intervention / Treatment: Diagnostic test: Lumentin® 44; Diagnostic test: Diluted Omnipaque®; Diagnostic test: Movprep®

• Study Type: Interventional
• Enrollment (Actual): 45
• Phase: Phase 2

Contacts and Locations

Study Locations

• Sweden
  • Malmö, Sweden, 20502
    • Department of medical imaging and function

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lumentin® 44; Contrast agent	Diagnostic test: Lumentin® 44; Contrast agent
Active Comparator: Diluted Omnipaque®; Contrast agent	Diagnostic test: Diluted Omnipaque®; Contrast agent
Active Comparator: Movprep®; Contrast agent	Diagnostic test: Movprep®; Contrast agent

What is the study measuring?

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 details5. Medium9. 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

Collaborators and Investigators

• Sponsor: Lument AB
• Investigators: Principal Investigator: Peter Leander, Ass. Prof., Skanes University Hospital

Publications and helpful links

General Publications

• Leander P, Stathis G, Casal-Dujat L, Boman K, Adnerhill I, Marsal J, Book O, Fork T. A novel food-based negative oral contrast agent compared with two conventional oral contrast agents in abdominal CT: a three-arm parallel blinded randomised controlled single-centre trial. Eur Radiol Exp. 2022 Apr 5;6(1):15. doi: 10.1186/s41747-022-00267-z.

Study record dates

Study Major Dates

• Study Start (Actual): November 28, 2017
• Primary Completion (Actual): September 30, 2018
• Study Completion (Actual): February 15, 2019

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 25, 2017
• First Posted (Actual): October 31, 2017

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 3, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: LUM-001

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No