FAPi-PET Imaging of in Vivo Fibrosis in Inflammatory Bowel Disease Patients
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Detection of areas with increased 68Ga-FAPi uptake in Crohn's disease patients
研究概览
简要总结
Our main objective is to evaluate the feasibility of 68Ga-FAPi PET/CT in detecting intestinal fibrosis in patients with IBD. To this end, we will determine 68Ga-FAPi uptake in IBD in relation to cellular FAP expression in intestinal biopsies and resection specimens.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Adults ≥18 years with confirmed diagnosis of Crohn's disease
- •AND one of the following:
- •Gastrointestinal complaints such as diarrhea, bloody and/ or lose stools and abdominal pain, or obstructive symptoms.
- •Increased CRP (>5 mg/L) and/or fecal calprotectin levels (>250 mg/kg)
- •Active disease confiremed by endoscopy ( endoscopic SES-CD score >3)
- •Active disease confirmed by IUS or MRI (bowel wall thickening, signs of active disease) Group 2
- •Adults ≥18 years with confirmed diagnosis of ulcerative colitis
- •AND one of the following:
- •Active disease confirmed by endoscopy (endoscopic Mayo score ≥ 2) or
- •Active disease confirmed by intestinal ultrasound (BWT > 3 mm in atleast one bowel segment and atleast one other pathological IUS parameter)
- •Increased CRP (>5 mg/L) and/or fecal calprotectin levels (>250 mg/kg)
排除标准
- •Pregnancy
- •Unable to provide informed consent
- •IBD-related surgeries < 5 years in medical history
- •Colorectal carcinoma
结局指标
主要结局
Detection of areas with increased 68Ga-FAPi uptake in Crohn's disease patients
时间窗: At baseline up to week 12 of study enrolment
Detection of areas with increased 68Ga-FAPi uptake (both visually as semi-quantitatively) in the terminal ileum and colon on baseline PET/CT of active Crohn's disease patients compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi PET imaging studies in patients not suffering from IBD (when signed informed consent is available).
Detection of areas with increased 68Ga-FAPi uptake in ulcerative colitis patients
时间窗: At baseline up to week 12 of study enrolment
Detection of areas with increased 68Ga-FAPi uptake (both visually as semi-quantitatively) in the terminal ileum and colon on baseline PET/CT of ulcerative colitis patients compared to bowel uptake reference values as derived in other Amsterdam UMC 68Ga-FAPi PET imaging studies in patients not suffering from IBD (when signed informed consent is available).
次要结局
- Visual and semi-quantitative evaluation of the pharmacokinetics (PK) of 68Ga-FAPi(At baseline up to week 12 of study enrolment)
- Protocol optimisation(At baseline up to week 12 of study enrolment)
- Minimal tracer injection dose(At baseline up to week 12 of study enrolment)
研究者
Dalia Lartey
Drs
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)