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

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02173964
Collaborator
(none)
58
Enrollment
1
Location
2
Arms
16
Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

  1. Background

  2. PET/CT (positron emission tomography/computed tomography) using FDG (fluorodeoxyglucose) is widely used for evaluation of cancer patients.

  3. Bowel uptake of FDG is a serious problem that hampers the proper reading of PET/CT.

  4. There is no widely-accepted method to reduce the bowel FDG uptake.

  5. Purpose

  6. To know whether pinverin (pinaverium bromide) application during PET/CT can reduce bowel uptake of FDG.

  7. Pinverin is a calcium-channel blocker that ameliorates the bowel contraction.

  8. Pinverin may be useful to reduce bowel FDG uptake by ameliorating the bowel contraction during PET/CT acquisition.

  9. Method

  10. Intervention versus control: administration of single tablet of pinverin (50mg) perorally versus simple water (~100mL).

  11. Timing of administration: At the time of FDG injection. PET/CT images will be acquired 1hr post FDG injection.

  12. Primary outcome

  13. SUV (standardized uptake value) difference between pinverin administered patient group versus control group.

  14. SUV (standardized uptake value) is calculated as: (decay corrected radioactivity in mCi/mL) x (body weight in g) / (injected radioactivity in mCi)

Condition or Disease Intervention/Treatment Phase
Phase 4

Study Design

Study Type:
Interventional
Actual Enrollment :
58 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
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
Study Start Date :
Jul 1, 2014
Actual Primary Completion Date :
Nov 1, 2015
Actual Study Completion Date :
Nov 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: pinaverium bromide

pinaverium bromide 50 mg tablet per oral administration one time

Drug: pinaverium bromide
pinverin 50 mg per oral single dose versus simple water ingestion
Other Names:
  • pinverin

    		•
    Placebo Comparator: water

    water ~100mL

    Drug: water
    same amount of water for pinverin administration
    Other Names:
  • water~100mL

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Bundang Hospital Seongnam Gyeonggi Korea, Republic of 463-707

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Won Woo Lee, MD, PhD, Seoul National University Bundang Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Won Woo Lee, Professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02173964
    Other Study ID Numbers:
    • Pin-2014-SNUBH
    First Posted:
    Jun 25, 2014
    Last Update Posted:
    Apr 15, 2016
    Last Verified:
    Apr 1, 2016
    Keywords provided by Won Woo Lee, Professor, Seoul National University Hospital
    fluorodeoxyglucose
    positron emission tomography
    computed tomography
    bowel
    pinaverium bromide
    Additional relevant MeSH terms:
    Pinaverium
    Bromides

    Study Results

    No Results Posted as of Apr 15, 2016