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

April 13, 2016 updated by: Won Woo Lee, Seoul National University Hospital

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

  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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

58

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi
      • Seongnam, Gyeonggi, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: pinaverium bromide
pinaverium bromide 50 mg tablet per oral administration one time
Drug: pinaverium bromide
pinverin 50 mg per oral single dose versus simple water ingestion
Other Names:
  • pinverin
Placebo Comparator: water
water ~100mL
Drug: water
same amount of water for pinverin administration
Other Names:
  • water~100mL

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 hour after FDG (the radiopharmaceutical for PET/CT) injection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Won Woo Lee, MD, PhD, Seoul National University Bundang Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

June 23, 2014

First Submitted That Met QC Criteria

June 23, 2014

First Posted (Estimate)

June 25, 2014

Study Record Updates

Last Update Posted (Estimate)

April 15, 2016

Last Update Submitted That Met QC Criteria

April 13, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pin-2014-SNUBH

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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