Virtual hIStology of Crohn's Disease Ex-vivo Resected Anatomical Lesions
ConditionCrohn Disease (CD)
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentral Hospital, Nancy, France
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
None
Trial population
Adults (≥18 years) diagnosed with Crohn's disease who are undergoing planned intestinal resection surgery at CHRU Nancy.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
60 Participants
are grouped into 1 trial groupGroup A: Crohn's Disease Patients Undergoing Intestinal Resection
Trial outcomes
Primary outcomes
1
Ex vivo MRI assessment of intestinal biophysical properties - T2 relaxometry
Measurement of T2 relaxometry (ms) of resected intestinal tissue using ex vivo MRI.
Time frame
Baseline (J0): day of surgery2
Ex vivo MRI assessment of intestinal biophysical properties - T1 relaxometry
Measurement of T1 relaxometry (ms) of resected intestinal tissue using ex vivo MRI.
Time frame
Baseline (J0): day of surgery3
Ex vivo MRI assessment of intestinal electrical properties - conductivity
Measurement of tissue conductivity (S/m) using MR electrical properties tomography (MR-EPT).
Time frame
Baseline (J0): day of surgery4
Ex vivo MRI assessment of intestinal electrical properties - permittivity
Measurement of tissue relative permittivity (unitless) using MR electrical properties tomography (MR-EPT).
Time frame
Baseline (J0): day of surgerySecondary outcomes
1
Histopathological quantification of intestinal fibrosis - total area
Measurement of fibrotic area (mm²) on the entire histological section from the area of maximal stenosis.
Time frame
Baseline (J0): day of surgery2
Histopathological quantification of intestinal inflammation - total area
Measurement of inflammatory area (mm²) on the entire histological section from the area of maximal stenosis.
Time frame
Baseline (J0): day of surgery3
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.
Time frame
Baseline (J0): day of surgery4
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.
Time frame
12 months post-surgerySponsors and contacts
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Source ClinicalTrials.gov
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