CompletedPhase 2

Trial Evaluating the Diagnostic Usefulness of Lumentin® 44 When Used as Contrast Agent

Sweden60 participantsStarted 2020-01-29

Plain-language summary

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

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Subjects of either gender at least 18 years of age at time of signing the informed consent. * Subjects with a confirmed CD diagnosis * Clinical indication for an MRE examination of the small bowel, i.e. need for disease status evaluation due to, for example, a relapse/flare, disease status evaluation before starting a new treatment, evaluation of therapeutic effect of given treatment, change in symptomatology, follow-up of longstanding disease, and/or pre-operative mapping/investigation Exclusion Criteria: * Clinical suspicion of a severe general or an acute abdominal condition (i.e. bowel obstruction, bowel perforation, severe bleeding or severe inflammation), requiring acute or subacute management. * Moderate to severe dysphagia * Known allergy to egg albumin * Known severe retention of urine * Known cardiac arrythmia * Having untreated glaucoma * Having known manifest thyrotoxicosis * Having known phenylketonuria * Having known Glucose-6-phosphatase deficiency * Contraindicated IV administration of contrast media used in MRE or CTE * Known sensitivity to any of the components of the investigational product * Having metallic implants incompatible with MRI examination

What they're measuring

RCDAS score

Timeframe: 1 Hour

Trial details

NCT IDNCT04321941

SponsorLument AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-04-04