At a glance
ClinicalIndex Comparison Record- ✓Healthy volunteers aged ≥18 years at time of informed consent
- ✓Females must have negative pregnancy test, be surgically sterile, or postmenopausal
- ✕eGFR <60 mL/min/1.73 m²
- ✕History of drug-related reaction to gadolinium contrast agents
- ✕Gadolinium injection within the last 4 weeks
- ✕Claustrophobia incompatible with MRE examination
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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.
In Brief
A Phase 2 clinical trial evaluating Lumentin® 44 Powder for oral foam for Healthy. Completed, enrolled 10 participants across 1 site.
Detailed 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.
Study Details
Timeline
Interventions
Lumentin® 44 is a foam for oral use.