Virtual hIStology of Crohn's Disease Ex-vivo Resected Anatomical Lesions (VISCERAL)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Crohn Disease (CD)

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Guillaume DROUOT, PhD; Phone Number: +33383157666; Email: g.drouot@chru-nancy.fr

Study Locations

• France
  • Vandœuvre-lès-Nancy, France, 54511
    • CHRU Nancy
    • Contact: Guillaume DROUOT, PhD; Phone Number: +33383157666; Email: g.drouot@chru-nancy.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults (≥18 years) diagnosed with Crohn's disease who are undergoing planned intestinal resection surgery at CHRU Nancy.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

- None

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ex vivo MRI assessment of intestinal biophysical properties - T2 relaxometry	Measurement of T2 relaxometry (ms) of resected intestinal tissue using ex vivo MRI.	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.	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).	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).	Baseline (J0): day of surgery
Ex vivo MRI assessment of intestinal mechanical properties - elastography	Measurement of tissue stiffness (kPa) using magnetic resonance elastography.	Baseline (J0): day of surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Histopathological quantification of intestinal fibrosis - total area	Measurement of fibrotic area (mm²) on the entire histological section from the area of maximal stenosis.	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.	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.	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.	12 months post-surgery

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): April 1, 2028

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 25, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 2025PI054

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No