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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
Sponsor:
Collaborator:
LINK Medical Research
Information provided by (Responsible Party):
Lument AB

Brief 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


Condition or disease Intervention/treatment Phase
Crohn Disease Diagnostic Test: Lumentin Diagnostic Test: Movprep Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 55 participants
Allocation: Randomized
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
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Contacts
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Contact: Johan Quensel, PhD +46760466744 jq@qcrc.se
Contact: Olof Böök, CEO olof.book@lumentab.com

Locations
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Sweden
Department of medical imaging and function Recruiting
Malmö, Sweden, 20502
Contact: Jan Marsal, Dr    +4646177003    jan.marsal@med.lu.se   
Principal Investigator: Jan Marsal, Dr., PhD         
Sponsors and Collaborators
Lument AB
LINK Medical Research
Investigators
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Principal Investigator: Jan Marsal, Dr. Skane University Hospital
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Responsible Party: Lument AB
ClinicalTrials.gov Identifier: NCT04321941    
Other Study ID Numbers: LUM-002
2019-002093-32 ( EudraCT Number )
First Posted: March 25, 2020    Key Record Dates
Last Update Posted: March 27, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases