Status:
COMPLETED
Trial Evaluating the Diagnostic Usefulness of Lumentin® 44 When Used as Contrast Agent
Lead Sponsor:
Lument AB
Collaborating Sponsors:
LINK Medical Research
Conditions:
Crohn Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 MR...
Detailed Description
The trial is a phase 2 randomised, open, non-inferiority within patient-controlled multi-centre trial. Patient recruitment will take place at 1 or more study centres by clinicians specialised in gast...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 29 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 12 2022
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04321941
Start Date
January 29 2020
End Date
May 12 2022
Last Update
July 29 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Department of medical imaging and function
Malmo, Sweden, 20502