NCT07413653

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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
22mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Apr 2026Apr 2028

First Submitted

Initial submission to the registry

February 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2028

Last Updated

February 25, 2026

Status Verified

February 1, 2026

Enrollment Period

1 year

First QC Date

February 9, 2026

Last Update Submit

February 24, 2026

Conditions

Crohn Disease (CD)

Outcome Measures

Primary Outcomes (5)

  • 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 Outcomes (4)

  • Histopathological quantification of intestinal fibrosis - total area

    Baseline (J0): day of surgery

  • Histopathological quantification of intestinal inflammation - total area

    Baseline (J0): day of surgery

  • Association between ex vivo and in vivo MRI lesion characteristics

    Baseline (J0): day of surgery

  • Association between intestinal lesion characteristics and clinical events

    12 months post-surgery

Study Arms (1)

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.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHRU Nancy

Vandœuvre-lès-Nancy, 54511, France

Location

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Central Study Contacts

Guillaume DROUOT, PhD

CONTACT

+33383157666g.drouot@chru-nancy.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 17, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

April 1, 2028

Last Updated

February 25, 2026

Record last verified: 2026-02

Locations

FR(1)