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

Status

Not yet recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT07413653

Acronym

VISCERAL

Enrollment

Registered

2026-02-17

Start date

2026-04-01

Completion date

2028-04-01

Last updated

2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn Disease (CD)

Brief 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. 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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Ex vivo MRI assessment of intestinal biophysical properties - T2 relaxometry	Baseline (J0): day of surgery	Measurement of T2 relaxometry (ms) of resected intestinal tissue using ex vivo MRI.
Ex vivo MRI assessment of intestinal biophysical properties - T1 relaxometry	Baseline (J0): day of surgery	Measurement of T1 relaxometry (ms) of resected intestinal tissue using ex vivo MRI.
Ex vivo MRI assessment of intestinal electrical properties - conductivity	Baseline (J0): day of surgery	Measurement of tissue conductivity (S/m) using MR electrical properties tomography (MR-EPT).
Ex vivo MRI assessment of intestinal electrical properties - permittivity	Baseline (J0): day of surgery	Measurement of tissue relative permittivity (unitless) using MR electrical properties tomography (MR-EPT).
Ex vivo MRI assessment of intestinal mechanical properties - elastography	Baseline (J0): day of surgery	Measurement of tissue stiffness (kPa) using magnetic resonance elastography.

Secondary

Measure	Time frame	Description
Histopathological quantification of intestinal fibrosis - total area	Baseline (J0): day of surgery	Measurement of fibrotic area (mm²) on the entire histological section from the area of maximal stenosis.
Histopathological quantification of intestinal inflammation - total area	Baseline (J0): day of surgery	Measurement of inflammatory area (mm²) on the entire histological section from the area of maximal stenosis.
Association between ex vivo and in vivo MRI lesion characteristics	Baseline (J0): day of surgery	Correlation between lesion properties measured ex vivo and in vivo MRI parameters of the same lesions.
Association between intestinal lesion characteristics and clinical events	12 months post-surgery	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.

Countries

France

Contacts

CONTACTGuillaume DROUOT, PhD

g.drouot@chru-nancy.fr+33383157666

Outcome results