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Clinical Trial 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)


Clinical Trial Description

n/a


Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


NCT number NCT02173964
Study type Interventional
Source Seoul National University Hospital
Contact
Status Completed
Phase Phase 4
Start date July 2014
Completion date November 2015

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