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Not yet recruiting NCT07413653

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

— Observational Crohn Disease (CD)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Crohn Disease (CD). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
France
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Primary outcome measures

  • Ex vivo MRI assessment of intestinal biophysical properties - T2 relaxometry [Time frame: Baseline (J0): day of surgery]
  • Ex vivo MRI assessment of intestinal biophysical properties - T1 relaxometry [Time frame: Baseline (J0): day of surgery]
  • Ex vivo MRI assessment of intestinal electrical properties - conductivity [Time frame: Baseline (J0): day of surgery]
  • Ex vivo MRI assessment of intestinal electrical properties - permittivity [Time frame: Baseline (J0): day of surgery]
  • Ex vivo MRI assessment of intestinal mechanical properties - elastography [Time frame: Baseline (J0): day of surgery]
Secondary outcome measures (4)
  • Histopathological quantification of intestinal fibrosis - total area [Time frame: Baseline (J0): day of surgery]
  • Histopathological quantification of intestinal inflammation - total area [Time frame: Baseline (J0): day of surgery]
  • Association between ex vivo and in vivo MRI lesion characteristics [Time frame: Baseline (J0): day of surgery]
  • Association between intestinal lesion characteristics and clinical events [Time frame: 12 months post-surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

France · 1 center
  • CHRU Nancy — Vandœuvre-lès-Nancy

Identifiers

NCT: NCT07413653 · 2025PI054

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗