MedTrace Logo

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

NCT04321941 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-07-29

No results posted yet for this study

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

Conditions

  • Crohn Disease

Interventions

DIAGNOSTIC_TEST

Lumentin

Contrast agent used in combination with CTE

DIAGNOSTIC_TEST

Movprep

Contrast agent used in combination with MRE

Sponsors & Collaborators

  • LINK Medical Research

    collaborator UNKNOWN

  • Lument AB

    lead INDUSTRY

Principal Investigators

  • Jan Marsal, Dr. · Skane University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-01-29
Primary Completion
2022-04-04
Completion
2022-05-12

Countries

  • Sweden

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04321941 on ClinicalTrials.gov