drugset / Trial / NCT02173964

Pinverin Application Trial to Reduce Bowel Uptake of FDG (Fluorodeoxyglucose)

NCT02173964

Phase 4 Completed 58 enrolled Seoul National University Hospital
RandomizedParallel-groupOpen-labelDiagnostic

Summary

1. Background 1. PET/CT (positron emission tomography/computed tomography) using FDG (fluorodeoxyglucose) is widely used for evaluation of cancer patients. 2. Bowel uptake of FDG is a serious problem that hampers the proper reading of PET/CT. 3. There is no widely-accepted method to reduce the bowel FDG uptake. 2. Purpose 1. To know whether pinverin (pinaverium bromide) application during PET/CT can reduce bowel uptake of FDG. 2. Pinverin is a calcium-channel blocker that ameliorates the bowel contraction. 3. Pinverin may be useful to reduce bowel FDG uptake by ameliorating the bowel contraction during PET/CT acquisition. 3. Method 1. Intervention versus control: administration of single tablet of pinverin (50mg) perorally versus simple water (\~100mL). 2. Timing of administration: At the time of FDG injection. PET/CT images will be acquired 1hr post FDG injection. 4. Primary outcome 1. SUV (standardized uptake value) difference between pinverin administered patient group versus control group. 2. SUV (standardized uptake value) is calculated as: (decay corrected radioactivity in mCi/mL) x (body weight in g) / (injected radioactivity in mCi)

Timeline

Start
2014-07
Primary completion
2015-11
Completion
2015-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Pinaverium Small molecule 50 mg Oral

Indications