Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04321941 |
| Other study ID # |
LUM-002 |
| Secondary ID |
2019-002093-32 |
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
January 29, 2020 |
| Est. completion date |
May 12, 2022 |
Study information
| Verified date |
July 2022 |
| Source |
Lument AB |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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
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
gastroenterology. MRE and CTE examinations will be performed at the department of Radiology
at a hospital or private practise that performs radiology. Participating radiology department
or private practice need to be certified to perform the examination at Skåne University
Hospital, SUS, Malmö, Sweden.
Male and female subjects with a diagnosis of CD 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 MRE/CTE examinations should go through the
end of treatment procedures at visit 7.
Subjects interested in participating in the trial will be screened for eligibility at visit
1. After receiving information about the trial according to the procedures for subject
information and consent (see section 14.3) and found eligible according to the in-/exclusion
criteria, patients will be included in the trial and randomised. After randomisation, the
subject's demography, medical history and concomitant illness and medical treatment will be
noted
Subjects will attend two examinations during the course of the trial:
- A CTE
- An MRE The order in which the MRE and CTE-L is performed will be randomised. Date and
time for the patient's MRE examination will be booked at the department of radiology
when the subject have been randomised. The date of CTE examination will then be booked
two to three weeks apart from the MRE, either before or after according to the
randomisation, to ensure both a proper washout period of given medical compounds and a
minimal risk of change in status of the disease.
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.
The radiologist assessment, according to the RCDAS, of the CTE and MRE examinations will be
performed by the investigators specialised in abdominal imaging at the department of
radiology. The radiologist assessment of one patient's CTE and MRE examinations will not be
performed by the same investigator in order to avoid that one assessment influence the other.
Appointment of assessor for each examination will be performed by randomisation.
Pseudonymised assessment of CTE and MRE scans will be performed in batches of approximately 5
scans. Patient identification details will be removed from the scans and replaced by a code
and the scans will be saved in a separate archive. The assessor will not have access to the
code list.
After the completion of the trial, a blinded assessment of all pseudonymised images will be
performed where the investigators assess the images initially assessed by the other
investigator. The data will be used to document inter-reader variability.
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 once all subjects have
completed the trial. The CDMRIS scale and Lémann Index are described below. All assessments
of the CTE and MRE images will be performed by the investigators at the department of
radiology. Only the principal investigator will assess images according to Lémann and CDMRIS.
Other assessments:
During the time the subjects drink the contrast agent prior to the MRE/CTE scan, they will be
asked to complete a questionnaire assessing taste, smell, consistency, fullness and ability
to swallow the contrast agent.
The subjects will be contacted 2 days after the MRE and CTE examination for control of any
potential AE and concomitant medication.
Subjects' experience of anxiety level at the CTE and MRE examinations will be investigated by
the use of the State-Trait Anxiety Inventory for Adults questionnaires. The State
questionnaire STAI-S consists of 20 statements that evaluate how respondents feel at the
moment in terms of tension, apprehension, nervousness, and worry. The inventory might also be
used to evaluate how respondents felt at a particular situation in the recent past. STAI-S
has been found to be sensitive to changes in transitory anxiety. The Trait questionnaire
STAI-T consist of 20 statements that evaluate how respondents feel in general and react to
stressful situations. The subjects will respond to the STAI-S directly after the CTE, and
MRE, as well as after optional capsule and ultrasound examinations respectively, when
remaining at the clinic, and also to the STAI-T directly after the second radiology
examination is performed.
A subset of up to 20 subjects will be asked to perform a capsule endoscopy examination and/or
ultrasound examination.
- The capsule examination enables visualisation of both the small bowel and the colon
mucosa in one procedure. The Crohn's disease severity and presence of strictures, ulcers
and other lesions will be evaluated. In the small bowel and colon.
- The ultrasound examination enables visualisation of bowel wall thickening and flow and
presence of ulcers, strictures, fistulas and abscesses.
