Crohn Disease (CD)VISCERALNCT07413653
Virtual hIStology of Crohn's Disease Ex-vivo Resected Anatomical Lesions
An observational study of Crohn Disease (CD), run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Crohn's disease is a chronic, incurable inflammatory bowel disease with an unpredictable course, characterized by alternating remission and inflammatory flares. Current follow-up strategies are poorly suited to early flare detection, leading to uncontrolled disease progression and complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease (CD)
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 25 Sep 2026to 1 Oct 2028
- Phase
- Observational
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: Adults (≥18 years) diagnosed with Crohn's disease who are undergoing planned intestinal resection surgery at CHRU Nancy.
Who may be able to join
- Age ≥ 18 years.
- Diagnosis of Crohn's disease and undergoing intestinal resection surgery at CHRU Nancy.
- Patient has not objected to the reuse of personal data and biological samples for the purposes of this research.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHRU Nancy
Vandœuvre-lès-Nancy, 54511
Guillaume DROUOT, PhD, +33383157666, g.drouot@chru-nancy.fr
About this study
Crohn's disease is a chronic, incurable inflammatory bowel disease with an unpredictable course, characterized by alternating remission and inflammatory flares. Current follow-up strategies are poorly suited to early flare detection, leading to uncontrolled disease progression and complications. A major clinical challenge is distinguishing reversible inflammatory activity from irreversible intestinal fibrosis, as existing imaging techniques lack specificity. This study aims to perform comprehensive ex vivo multiparametric MRI, combined with biophysical measurements and histopathology, on resected intestinal specimens to precisely map inflammation and fibrosis and to validate in vivo MRI-derived biomarkers for personalized therapeutic decision-making.
- Conditions
- Crohn Disease (CD)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Crohn's Disease Patients Undergoing Intestinal Resection | Patients with Crohn's disease undergoing planned intestinal resection surgery. Resected intestinal specimens will be analyzed ex vivo using multiparametric magnetic resonance imaging, biophysical measurements (mechanical and electrical properties), and histopathological examination. No experimental intervention is performed on participants beyond standard surgical care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ex vivo MRI assessment of intestinal biophysical properties - T2 relaxometry
Measurement of T2 relaxometry (ms) of resected intestinal tissue using ex vivo MRI.
Measured: Baseline (J0): day of surgery
Ex vivo MRI assessment of intestinal biophysical properties - T1 relaxometry
Measurement of T1 relaxometry (ms) of resected intestinal tissue using ex vivo MRI.
Measured: Baseline (J0): day of surgery
Ex vivo MRI assessment of intestinal electrical properties - conductivity
Measurement of tissue conductivity (S/m) using MR electrical properties tomography (MR-EPT).
Measured: Baseline (J0): day of surgery
Ex vivo MRI assessment of intestinal electrical properties - permittivity
Measurement of tissue relative permittivity (unitless) using MR electrical properties tomography (MR-EPT).
Measured: Baseline (J0): day of surgery
Ex vivo MRI assessment of intestinal mechanical properties - elastography
Measurement of tissue stiffness (kPa) using magnetic resonance elastography.
Measured: Baseline (J0): day of surgery
Secondary outcomes (4)
Histopathological quantification of intestinal fibrosis - total area
Measurement of fibrotic area (mm²) on the entire histological section from the area of maximal stenosis.
Measured: Baseline (J0): day of surgery
Histopathological quantification of intestinal inflammation - total area
Measurement of inflammatory area (mm²) on the entire histological section from the area of maximal stenosis.
Measured: Baseline (J0): day of surgery
Association between ex vivo and in vivo MRI lesion characteristics
Correlation between lesion properties measured ex vivo and in vivo MRI parameters of the same lesions.
Measured: Baseline (J0): day of surgery
Association between intestinal lesion characteristics and clinical events
Correlation between in vivo MRI-derived intestinal lesion characteristics and occurrence of clinical events (emergency visits for abdominal pain, hospitalizations for digestive causes, additional intestinal resection) within 12 months post-surgery.
Measured: 12 months post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start25 Sep 2026
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn Disease (CD)Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
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
- NCT07413653
- Sponsor's protocol ID
- 2025PI054
- Acronym
- VISCERAL
- Status last verified
- Oct 2026
- First submitted
- 9 Feb 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No