A Healthy Volunteer Trial Investigating MR-enterography Image Quality of Lumentin® 44

Healthy Clinical Trial

Official title: An Uncontrolled, Single Centre, Healthy Volunteer, Phase II Proof-of-concept Trial Investigating MR-enterography Image Quality of Lumentin® 44, a New Egg Albumen Based Oral Small Bowel Filling Contrast Agent.

Status Completed

Clinical Trial Summary

A healthy volunteer, open, PoC single center trial investigating a new oral contrast agent for use in combination of MR examination of the abdomen and pelvis. The main purpose of the trial is to evaluate if Lumentin® 44 used as a bowel filling agent in MRE examination generates images with acceptable diagnostic quality. In addition, the plasma electrolytes concentration levels, including, potassium, sodium, phosphate, and calcium, as well as ionized calcium will be evaluated over a 24 hour time period after intake of Lumentin.

Clinical Trial Description

This is an uncontrolled, single centre phase II trial. Enrolled HVs (n=10) will undergo Gd-enhanced MRE after oral intake of Lumentin® 44. Interested HVs will be identified primarily among medical students at the medical hospitals at Malmö and Lund. Posters will be placed at the departments and invitation letters will be handed out. The HVs interested in participating will be invited to attend a pre-screening visit where their suitability based on age and health status will be assessed. Fifteen HVs who fulfil the pre-screening criteria and are interested in participating will be asked to attend a screening visit at the clinic and if eligible for the trial they will then visit the clinic for the MRE assessment within 1-2 weeks. Only the initial 10 of the eligible HVs will be asked to come for the MRE examination and the remaining eligible subjects will be asked to stand by in case any of the 10 subjects are unable to come or cannot undergo the examination. HVs will be asked to fast for 6 hours prior to the examination on the day of the MRE examination. Small amount of clear liquid is allowed up to 2 decilitres. Prior to MRE, Lumentin® 44 will be provided to them in volumes of up to 1,500 mL and at least 1,100 mL of Lumentin® 44 must be drunk. The subjects will be asked to drink the solutions of oral contrast agent within 45 minutes to 1 hour. Subjects not able to drink at least 1.1 L of Lumentin® 44 will be withdrawn from the trial. Prior to the intake of Lumentin® 44, an IV antecubital cannula will be placed and used for blood sampling and administration of gadolinium (Gd) contrast agent during the MRE assessment. ;

Related Conditions & MeSH terms

• Healthy

• NCT number: NCT05781490
• Study type: Interventional
• Source: Lument AB
• Status: Completed
• Phase: Phase 2
• Start date: February 6, 2023
• Completion date: February 28, 2023