Clinical Trial of Pinverin (Pinaverium Bromide) to Reduce Bowel Uptake of FDG in a Variety of Cancer Patients Who Undergo FDG PET/CT
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- SUV (standardized uptake value)
研究概览
简要总结
-
Background
-
PET/CT (positron emission tomography/computed tomography) using FDG (fluorodeoxyglucose) is widely used for evaluation of cancer patients.
-
Bowel uptake of FDG is a serious problem that hampers the proper reading of PET/CT.
-
There is no widely-accepted method to reduce the bowel FDG uptake.
-
Purpose
-
To know whether pinverin (pinaverium bromide) application during PET/CT can reduce bowel uptake of FDG.
-
Pinverin is a calcium-channel blocker that ameliorates the bowel contraction.
-
Pinverin may be useful to reduce bowel FDG uptake by ameliorating the bowel contraction during PET/CT acquisition.
-
Method
-
Intervention versus control: administration of single tablet of pinverin (50mg) perorally versus simple water (~100mL).
-
Timing of administration: At the time of FDG injection. PET/CT images will be acquired 1hr post FDG injection.
-
Primary outcome
-
SUV (standardized uptake value) difference between pinverin administered patient group versus control group.
-
SUV (standardized uptake value) is calculated as: (decay corrected radioactivity in mCi/mL) x (body weight in g) / (injected radioactivity in mCi)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any cancer patients
- •Candidate of positron emission tomography/computed tomography
排除标准
- •Diabetes mellitus
- •Inflammatory bowel disease
- •Irritable bowel syndrome
- •Peritoneal carcinomatosis
- •Peritonitis
- •Abdominal pain
- •Medical test requiring bowel preparation within 1 month
- •History of abdominal surgery
- •Symptom or sign of colitis
- •Pregnancy or lactation
- •Hypersensitivity to pinaverium bromide
- •Lactate intolerance
- •Anit-depressant medication
研究组 & 干预措施
pinaverium bromide
pinaverium bromide 50 mg tablet per oral administration one time
干预措施: pinaverium bromide (Drug)
water
water ~100mL
干预措施: water (Drug)
结局指标
主要结局
SUV (standardized uptake value)
时间窗: 1 hour after FDG (the radiopharmaceutical for PET/CT) injection
SUV is the quantitative parameter of FDG uptake during PET/CT and represents the degree of relative FDG uptake in a specific lesion. SUV is calculated as: (decay-corrected radioactivity in mCi/mL) x (body weight in g) / (injected radioactivity in mCi). The unit of SUV is g/mL.
次要结局
未报告次要终点
研究者
Won Woo Lee
Professor
Seoul National University Hospital