Crohn DiseaseFast-MRNCT06526234
Performance of Non-injected MR Enterography Compared to a Conventional MR Enterography Protocol With Contrast Agent Injection
An observational study of Crohn Disease, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Entero-MRI is indicated in Crohn's disease as part of the initial work-up or follow-up (to assess response to treatment, complications). The protocol for carrying out the examination complies with precise specifications set out in international recommendations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- MRI
- Type of treatment
- Medical device
- How many people
- 250 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2023to 30 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patient with MR enterography examination for follow-up or suspected Crohn's disease
Who may be able to join
- Patient with MR enterography examination for follow-up or suspected Crohn's disease
- No Exclusion Criteria.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Entero-MRI is indicated in Crohn's disease as part of the initial work-up or follow-up (to assess response to treatment, complications). The protocol for carrying out the examination complies with precise specifications set out in international recommendations. To perform the test, the small intestine must be distended with a hyperosmolar product. This protocol is applied to all patients, with no distinction or adaptation.
The total duration of the examination is sometimes difficult for patients to bear. Ingestion of the product to obtain distension of the small intestine is often poorly tolerated by patients.
Read more
In a number of cases, the entero-MRI may have been normal due to symptomatology regression or other diagnosis. The patient therefore underwent a complete examination similar to that of a patient with a pathology requiring characterization.
In this context, the investigators hypothesize that fast MR sequences are sufficient to discriminate between normal and abnormal examinations.
- Conditions
- Crohn Disease
- Being tested
- MRI
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDevice
MR enterography
| Study group | Role | What they receive |
|---|---|---|
| Patients with Crohn's disease or suspected Crohn's disease | Not described Receives: Device: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence or absence of lesions detected visually by a radiologist on injection-free sequences versus conventional MR enterography.
Measured: Baseline (day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jul 2024
- Study start1 Jan 2023
- Primary completion31 May 2023
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Valérie LAURENT, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06526234
- Sponsor's protocol ID
- 2024PI153
- Acronym
- Fast-MR
- Status last verified
- Jan 2026
- First submitted
- 23 Jul 2024
- Last updated
- 28 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance of Non-injected MR Enterography Compared to a Conventional MR Enterography Protocol With Contrast Agent Injection
- ClinicalTrials.gov ID
- NCT06526234
- Acronym / sponsor ID
- Fast-MR / 2024PI153
- Conditions
- Crohn Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 May 2023 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 29 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Entero-MRI is indicated in Crohn's disease as part of the initial work-up or follow-up (to assess response to treatment, complications). The protocol for carrying out the examination complies with precise specifications set out in international recommendations. To perform the test, the small intestine must be distended with a hyperosmolar product. This protocol is applied to all patients, with no distinction or adaptation.
The total duration of the examination is sometimes difficult for patients to bear. Ingestion of the product to obtain distension of the small intestine is often poorly tolerated by patients.
In a number of cases, the entero-MRI may have been normal due to symptomatology regression or other diagnosis. The patient therefore underwent a complete examination similar to that of a patient with a pathology requiring characterization.
In this context, the investigators hypothesize that fast MR sequences are sufficient to discriminate between normal and abnormal examinations.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Crohn's disease or suspected Crohn's disease | – | Device: MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient with MR enterography examination for follow-up or suspected Crohn's disease
Key inclusion criteria (2 listed)
- Patient with MR enterography examination for follow-up or suspected Crohn's disease
- No Exclusion Criteria.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MRIMR enterography | Device | Patients with Crohn's disease or suspected Crohn's disease |
Primary outcome
Presence or absence of lesions detected visually by a radiologist on injection-free sequences versus conventional MR enterography.
Time frame: Baseline (day 0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn Disease, run by Central Hospital, Nancy, France at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence or absence of lesions detected visually by a radiologist on injection-free sequences versus conventional MR enterography. (time frame: Baseline (day 0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2026; AzTrials last refreshed its copy on 6 Nov 2026.