Pinverin Application Trial to Reduce Bowel Uptake of FDG (Fluorodeoxyglucose)
NCT ID: NCT02173964
Last Updated: 2016-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
58 participants
INTERVENTIONAL
2014-07-31
2015-11-30
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
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pinaverium bromide
pinaverium bromide 50 mg tablet per oral administration one time
pinaverium bromide
pinverin 50 mg per oral single dose versus simple water ingestion
water
water \~100mL
water
same amount of water for pinverin administration
Interventions
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pinaverium bromide
pinverin 50 mg per oral single dose versus simple water ingestion
water
same amount of water for pinverin administration
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Candidate of positron emission tomography/computed tomography
Exclusion Criteria
* 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
19 Years
80 Years
ALL
No
Sponsors
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Seoul National University Hospital
OTHER
Responsible Party
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Won Woo Lee
Professor
Principal Investigators
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Won Woo Lee, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Seoul National University Bundang Hospital
Locations
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Countries
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Other Identifiers
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Pin-2014-SNUBH
Identifier Type: -
Identifier Source: org_study_id
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