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

Study Overview
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Brief Summary
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Background PET/CT (positron emission tomography/computed tomography) using FDG (fluorodeoxyglucose) is widely used for evaluation of cancer patients. Bowel uptake of FDG is a serious problem that hampers the proper reading of PET/CT. There is no widely-accepted method to reduce the bowel FDG uptake. Purpose To know whether pinverin (pinaverium bromide) application during PET/CT can reduce bowel uptake of FDG. Pinverin is a calcium-channel blocker that ameliorates the bowel contraction. Pinverin may be useful to reduce bowel FDG uptake by ameliorating the bowel contraction during PET/CT acquisition. Method Intervention versus control: administration of single tablet of pinverin (50mg) perorally versus simple water ( 100mL). Timing of administration: At the time of FDG injection. PET/CT images will be acquired 1hr post FDG injection. Primary outcome SUV (standardized uptake value) difference between pinverin administered patient group versus control group. SUV (standardized uptake value) is calculated as: (decay corrected radioactivity in mCi/mL) x (body weight in g) / (injected radioactivity in mCi)

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

Conditions
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Cancer

Intervention / Treatment
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* Drug: pinaverium bromide
* Drug: water


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pinaverium bromide<br>pinaverium bromide 50 mg tablet per oral administration one time | Drug: pinaverium bromide<br>* pinverin 50 mg per oral single dose versus simple water ingestion<br>* Other names: pinverin;|
| Placebo Comparator: water<br>water  100mL | Drug: water<br>* same amount of water for pinverin administration<br>* Other names: water 100mL;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SUV (standardized uptake value) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fluorodeoxyglucose, positron emission tomography, computed tomography, bowel, pinaverium bromide