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

NCT02173964 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2016-04-15

No results posted yet for this study

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)

Conditions

Interventions

DRUG

pinaverium bromide

pinverin 50 mg per oral single dose versus simple water ingestion

DRUG

water

same amount of water for pinverin administration

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Won Woo Lee, MD, PhD · Seoul National University Bundang Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-11-30
Completion
2015-11-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02173964 on ClinicalTrials.gov