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Completed

NCT Number: NCT02173964

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

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)

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Key information

Conditions

Cancer Neoplasms

Age range

19 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pinaverium bromide

Drug

pinverin 50 mg per oral single dose versus simple water ingestion

Other names: pinverin

Water

Drug

same amount of water for pinverin administration

Other names: water~100mL

Primary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jun 25, 2014
Registry last updated
Apr 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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