Lument AB

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.

The trial is a phase 2 randomised, open, non-inferiority within patient-controlled multi-centre trial.
Male and female subjects with a diagnosis of Crohn´s Disease and a clinical indication for an MRE examination, who are at least 18 years of age and who provide a written informed consent, will be eligible for inclusion.
The trial period will be up to 16 weeks and consists of 7 visits (see schedule of events). All patients who have attended at least 1 of the Magnetic Resonance Enterography (MRE)/Computerised Tomography Enterography (CTE) examinations should go through the end of treatment procedures at visit 7.
Subjects will attend two examinations during the course of the trial:
* A CTE
* An MRE The Crohn's disease activity will be assessed radiologically on the MRE and CTE scans by identifying the presence and severity of a number of morphologic entities and dynamic signs in the SB and colon as described in the RCDAS.
Additional evaluation of CD activity and disease complication on the MRE and CTE images will be performed using the CDMRIS scale and Lémann Index respectively

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.