Virtual hIStology of Crohn's Disease Ex-vivo Resected Anatomical Lesions
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Ex vivo MRI assessment of intestinal biophysical properties - T2 relaxometry
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- 未提供
研究组 & 干预措施
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.
结局指标
主要结局
Ex vivo MRI assessment of intestinal biophysical properties - T2 relaxometry
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: Baseline (J0): day of surgery
Measurement of tissue stiffness (kPa) using magnetic resonance elastography.
次要结局
- 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)
研究者
Valérie LAURENT
Principal Investigator
Central Hospital, Nancy, France