NCT02173964

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
58

participants targeted

Target at P25-P50 for phase_4 cancer

Timeline
Completed

Started Jul 2014

Shorter than P25 for phase_4 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 23, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 25, 2014

Completed
6 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

April 15, 2016

Status Verified

April 1, 2016

Enrollment Period

1.3 years

First QC Date

June 23, 2014

Last Update Submit

April 13, 2016

Conditions

Cancer

Keywords

fluorodeoxyglucosepositron emission tomographycomputed tomographybowelpinaverium bromide

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

pinaverium bromide

EXPERIMENTAL

pinaverium bromide 50 mg tablet per oral administration one time

Drug: pinaverium bromide

water

PLACEBO COMPARATOR

water \~100mL

Drug: water

Interventions

pinaverium bromideDRUG

pinverin 50 mg per oral single dose versus simple water ingestion

Also known as: pinverin
pinaverium bromide
waterDRUG

same amount of water for pinverin administration

Also known as: water~100mL
water

Eligibility Criteria

Age19 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Any cancer patients
  • Candidate of positron emission tomography/computed tomography

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

MeSH Terms

Conditions

Neoplasms

Interventions

pinaveriumWater

Intervention Hierarchy (Ancestors)

HydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen Compounds

Study Officials

  • Won Woo Lee, MD, PhD

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 23, 2014

First Posted

June 25, 2014

Study Start

July 1, 2014

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

April 15, 2016

Record last verified: 2016-04

Locations

KR(1)