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

Phase 4

Completed

• Conditions: Cancer
• Interventions: Drug: pinaverium bromide; Drug: water

• Registration Number: NCT02173964
• Lead Sponsor: Seoul National University Hospital

Brief 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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-06-23
• Study First Submitted QC: 2014-06-23
• Study First Posted: 2014-06-25
• Study Start: 2014-07
• Primary Completion: 2015-11
• Study Completion: 2015-11
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-13
• Last Update Posted: 2016-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
pinaverium bromide	pinaverium bromide	pinaverium bromide 50 mg tablet per oral administration one time
water	water	water \~100mL

Primary Outcome Measures

Name	Time	Method
SUV (standardized uptake value)	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.

Trial Locations

Locations (1)

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggi, Korea, Republic of