68Ga-grazytracer PET/CT Study in Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 69
- 试验地点
- 1
- 主要终点
- Maximum Standardized uptake value
研究概览
简要总结
This is a single-centre, prospective, observational cohort study in which 69 patients with inflammatory bowel disease (IBD) were recruited to undergo 68Ga-grazytracer PET/CT imaging in patients with IBD to investigate the feasibility of early sensitive detection or prediction of the response to medication in patients with inflammatory bowel disease on 68Ga-grazytracer PET/CT and early prediction of the The feasibility of 68Ga-grazytracer PET/CT for early detection or prediction of response to drug therapy and early prediction of long-term prognosis in patients with inflammatory bowel disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 18-80 years old; Clinical diagnosis of inflammatory bowel disease (active stage); Not having received treatment within 4 weeks prior to undergoing PET/CT examination; Received endoscopy within 7 days before and after PET/CT examination; Signing an informed consent form for PET/CT examination and volunteering to participate in this study.
排除标准
- •No signed informed consent or unspecified diagnosis; Female subjects are pregnant or breastfeeding and male subjects are preparing for pregnancy; Those who are unfit to perform (concomitant severe and/or uncontrollable and/or unstable disease, developer allergy) or who are unable to complete imaging such as PET for specific reasons (needle-sickness, blood-sickness, claustrophobia); Colitis other than inflammatory bowel disease (infectious or ischaemic colitis); Patients who have undergone colon resection.
研究组 & 干预措施
before-after study in the same patient
About 69 patients with inflammatory bowel disease are planned to be included in this study. The screened subjects will undergo 68Ga-grazytracer PET/CT imaging before and at 2 weeks after drug therapy, and the investigators will collect clinical information from the patients, collect blood samples for granzyme B levels, and analyse the imaging results for data analysis.
干预措施: 68Ga-grazytracer PET/CT Scan (Diagnostic Test)
结局指标
主要结局
Maximum Standardized uptake value
时间窗: 1 day from injection of the tracer
68Ga-grazytracer maximum standardised uptake value (SUVmax) in the subject's primary and/or lesions
次要结局
未报告次要终点