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

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02173964

Enrollment

Registered

2014-06-25

Start date

2014-07-31

Completion date

2015-11-30

Last updated

2016-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer

Keywords

fluorodeoxyglucose, positron emission tomography, computed tomography, bowel, pinaverium bromide

Brief 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)

Interventions

DRUGpinaverium bromide

pinverin 50 mg per oral single dose versus simple water ingestion

DRUGwater

same amount of water for pinverin administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Any cancer patients * Candidate of positron emission tomography/computed tomography

Exclusion criteria

* Diabetes mellitus * Inflammatory bowel disease * Irritable bowel syndrome * Peritoneal carcinomatosis * Peritonitis * Abdominal pain * Diarrhea * 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

Design outcomes

Primary

Measure	Time frame	Description
SUV (standardized uptake value)	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.

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026