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NCT Number: NCT07413653

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

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.

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Key information

Conditions

Crohn Disease (CD) Crohn Disease Digestive System Diseases Gastroenteritis Gastrointestinal Diseases Inflammatory Bowel Diseases Intestinal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Ex vivo MRI assessment of intestinal biophysical properties - T2 relaxometry

    Time frame: Baseline (J0): day of surgery

    Measurement of T2 relaxometry (ms) of resected intestinal tissue using ex vivo MRI.

  2. Ex vivo MRI assessment of intestinal biophysical properties - T1 relaxometry

    Time frame: Baseline (J0): day of surgery

    Measurement of T1 relaxometry (ms) of resected intestinal tissue using ex vivo MRI.

  3. Ex vivo MRI assessment of intestinal electrical properties - conductivity

    Time frame: Baseline (J0): day of surgery

    Measurement of tissue conductivity (S/m) using MR electrical properties tomography (MR-EPT).

  4. Ex vivo MRI assessment of intestinal electrical properties - permittivity

    Time frame: Baseline (J0): day of surgery

    Measurement of tissue relative permittivity (unitless) using MR electrical properties tomography (MR-EPT).

  5. Ex vivo MRI assessment of intestinal mechanical properties - elastography

    Time frame: Baseline (J0): day of surgery

    Measurement of tissue stiffness (kPa) using magnetic resonance elastography.

Secondary outcomes

  1. Histopathological quantification of intestinal fibrosis - total area

    Time frame: Baseline (J0): day of surgery

    Measurement of fibrotic area (mm²) on the entire histological section from the area of maximal stenosis.

  2. Histopathological quantification of intestinal inflammation - total area

    Time frame: Baseline (J0): day of surgery

    Measurement of inflammatory area (mm²) on the entire histological section from the area of maximal stenosis.

  3. Association between ex vivo and in vivo MRI lesion characteristics

    Time frame: Baseline (J0): day of surgery

    Correlation between lesion properties measured ex vivo and in vivo MRI parameters of the same lesions.

  4. Association between intestinal lesion characteristics and clinical events

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Guillaume DROUOT, PhD

CONTACT

[email protected]

+33383157666

Sponsors and collaborators

Lead sponsor

Central Hospital, Nancy, France

Other

Registry information

Acronym: VISCERAL

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Feb 17, 2026
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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