Trial Evaluating the Diagnostic Usefulness of Lumentin® 44 When Used as Contrast Agent
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|ClinicalTrials.gov Identifier: NCT04321941|
Recruitment Status : Recruiting
First Posted : March 25, 2020
Last Update Posted : March 27, 2020
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
|Condition or disease||Intervention/treatment||Phase|
|Crohn Disease||Diagnostic Test: Lumentin Diagnostic Test: Movprep||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||55 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||Within patient comparison of diagnostic methods|
|Masking:||Single (Outcomes Assessor)|
|Masking Description:||Blinded evaluation of MRE and CTE images respectively|
|Official Title:||Randomised, Open, Non-inferiority Within Patient-controlled Trial Evaluating the Diagnostic Usefulness of Lumentin® 44 When Used as Contrast Agent in CT-enterography as Compared to MRI- Enterography in Patients With Small Bowel Crohn's Disease|
|Actual Study Start Date :||January 29, 2020|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2020|
Experimental: CTE (Computerised Tomography Enterography)
CTE examination performed with experimental contrast agent, Lumentin.
Diagnostic Test: Lumentin
Contrast agent used in combination with CTE
Active Comparator: MRE (Magnetic Resonance Enterography)
Comparative diagnostic method performed with the contrast agent Movprep®
Diagnostic Test: Movprep
Contrast agent used in combination with MRE
- RCDAS score [ Time Frame: 1 Hour ]Radiological Crohn's Disease Activity Score based on 18 morphologic entities and dynamic signs in the SB and colon. The score range from 0 to 34.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04321941
|Contact: Johan Quensel, PhDfirstname.lastname@example.org|
|Contact: Olof Böök, CEOemail@example.com|
|Department of medical imaging and function||Recruiting|
|Malmö, Sweden, 20502|
|Contact: Jan Marsal, Dr +4646177003 firstname.lastname@example.org|
|Principal Investigator: Jan Marsal, Dr., PhD|
|Principal Investigator:||Jan Marsal, Dr.||Skane University Hospital|