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

Seoul National University

Status and phase: Completed; Phase 4

Conditions: Cancer

Treatments: Drug: water; Drug: pinaverium bromide

Study type: Interventional

Funder types: Other

Identifiers

NCT02173964

Pin-2014-SNUBH

Details and patient eligibility

About

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)

Enrollment: 58 patients

Sex: All

Ages: 19 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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58 participants in 2 patient groups, including a placebo group

pinaverium bromide

Experimental group

Description:

pinaverium bromide 50 mg tablet per oral administration one time

Treatment:

Drug: pinaverium bromide

water

Placebo Comparator group

Description:

water \~100mL

Treatment:

Drug: water