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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02173964
• Other study ID #: Pin-2014-SNUBH
• Status: Completed
• Phase: Phase 4
• First received: June 23, 2014
• Last updated: April 13, 2016
• Start date: July 2014
• Est. completion date: November 2015

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: November 2015
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Cancer

Intervention

Drug:
• pinaverium bromide
pinverin 50 mg per oral single dose versus simple water ingestion
• water
same amount of water for pinverin administration

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No