Early MRI Prediction of Response to Medical Therapy and Mucosal Healing in Small Bowel Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 1
- 主要终点
- Prediction of therapeutic response in patients with Crohns disease
研究概览
简要总结
The investigators plan a prospective study designed to optimize and translate noncontrast, novel Magnetic Resonance Imaging (MRI) techniques for detecting and measuring intestinal inflammation as well as for allowing early prediction of response to medical therapy in small bowel Crohn's Disease (CD).
详细描述
The investigators plan to evaluate novel MRI techniques to measure: 1) mesenteric/intestinal blood flow using phase-contrast cine MRI, 2) intestinal motility (peristalsis) using dynamic cine MRI, and 3) bowel wall perfusion and molecular water diffusion. Precise objective measurements of diseased bowel blood flow (in ml/min) and bowel motility (in contractions per minute) are not currently used in the clinical care of CD patients, while diffusion-weighted imaging is typically used in a qualitative manner. None of these techniques have been evaluated for predicting eventual response to therapy or correlated with endoscopic mucosal healing in pediatric or adult CD.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 11 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Control Group
- •Be able to tolerate up to 45 minutes in an MRI scanner
- •Newly Diagnosed Crohns Group
- •Newly diagnosed, pathology-confirmed diagnosis of small bowel Crohn's disease,
- •Expected to receive infliximab (Remicade; Janssen Biotech, Inc.) or other anti-Tumor Necrosis Factor (anti-TNF) medical therapy,
- •Between 11 to 25 years of age and able to assent/consent,
- •Be available for follow-up MRI at 4-weeks and 6-months after the initiation of treatment,
- •Be able to tolerate up to 45 minutes in an MRI scanner.
排除标准
- •Healthy Control Group
- •Inability to obtain assent/consent,
- •Inability to tolerate 45 minutes in an MRI scanner,
- •Contraindication to MRI (e.g., MRI incompatible implant or support device),
- •Previous (remote) diagnosis or treatment of inflammatory bowel disease or other intestinal disease,
- •History of intra-abdominal surgery, including surgery on the intestine,
- •Pregnancy. Point-of-care urine pregnancy testing will be performed on all female study participants of reproductive potential (pediatric and adult) prior to each research MRI exam.
- •Newly Diagnosed Crohns Group
- •Inability to obtain assent/consent,
- •Inability to tolerate 45 minutes in an MRI scanner,
- •Contraindication to MRI (e.g., MRI incompatible implant or support device),
- •Previous (remote) diagnosis or treatment of inflammatory bowel disease,
- •History of intra-abdominal surgery, including surgery on the intestine,
- •Known bleeding disorder/coagulopathy (contraindication for adult subjects, as this may increase the risk of research colonoscopy),
- •Pregnancy. Point-of-care urine pregnancy testing will be performed on all female study participants of reproductive potential (pediatric and adult) prior to each research MRI exam.
结局指标
主要结局
Prediction of therapeutic response in patients with Crohns disease
时间窗: 30 minutes
Assess novel MRI techniques for ability to predict early response to infliximab therapy in 20 newly diagnosed small bowel CD patients.
次要结局
未报告次要终点