NCT02173964

Clinical Trial of Pinverin (Pinaverium Bromide) to Reduce Bowel Uptake of FDG in a Variety of Cancer Patients Who Undergo FDG PET/CT

Completed Phase 4 Last updated 13 April 2016

What this trial tests

Phase 4 trial testing pinaverium bromide in Cancer in 58 participants. Completed in 1 November 2015.

Timeline

1 July 2014

Primary endpoint
1 November 2015

1 November 2015

Quick facts

Lead sponsor	Seoul National University Hospital
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	58
Start date	1 July 2014
Primary completion	1 November 2015
Estimated completion	1 November 2015
Sites	1 location across South Korea

Drugs / interventions tested

• pinaverium bromide — full drug profile →
• water (WATER) — full drug profile →

Conditions studied

• Cancer — all drugs for Cancer →

Sponsor

Seoul National University Hospital

Who can join

Adults 19 to 80, any sex, with Cancer. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

• SUV (standardized uptake value)
  Time frame: 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.

Sponsor's own description

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)

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.