FDG Uptake in Vaginal Tampons is Due to Urine

Overview

The etiology of FDG uptake in vaginal tampons during PET/CT examinations remains unclear and can potentially impair image interpretation. The aim of this study is to determine the etiology of this artefact and identify potential means how to prevent it.

Full Title of Study: “Source and Prevention of Urinary Contamination of Vaginal Tampons During 18F-2-fluoro-2-deoxy-D-glucose (FDG) Positron Emission Tomography (PET) Examinations”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Diagnostic
    • Masking: Double (Participant, Investigator)
  • Study Primary Completion Date: August 2, 2010

Detailed Description

In this prospective, Institutional Review board approved study we included 44 women referred to FDG PET/CT for staging or follow-up in an oncology setting. All women were provided a normal commercial or modified vaginal tampon with a silicon coated base to be used during examination. Images were analyzed to determine the localization and the FDG uptake in the tampons. Between the uptake phase and imaging, all patients were asked to void. After image acquisition, tampons were individually analyzed for creatinine concentration, blood traces, position relative to the pubococcygeal line, and FDG activity. Statistical significance was determined by means of the Mann-Whitney U test.

Interventions

  • Device: modified vaginal tampon
    • modified vaginal tampons versus unmodified vaginal tampons, comparing the urinary contamination

Arms, Groups and Cohorts

  • Experimental: Modified vaginal tampons
    • Patients using modified vaginal tampons during FDG PET/CT
  • Placebo Comparator: Unmodified vaginal tampons
    • Patients using unmodified vaginal tampons during FDG PET/CT

Clinical Trial Outcome Measures

Primary Measures

  • Number of FDG Positive Tampoons
    • Time Frame: 1 month
    • Number of FDG positive Tampoons with an SUV > 3

Secondary Measures

  • Tampon Position Relative to the Pubococcygeal Line
    • Time Frame: 1 month
    • measure tampon position in regard to the pubococcygeal line to identify if positioning is responsible for urinary contamination.

Participating in This Clinical Trial

Inclusion Criteria

premenopausal women with known or suspected malignancies who regularly used vaginal tampons during menstruation and thus were familiar with their use Exclusion criteria:

No cervical or genital carcinoma. No vaginal infection.

Gender Eligibility: Female

Minimum Age: 20 Years

Maximum Age: 48 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Irene Burger
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Irene Burger, Attending physician – University of Zurich
  • Overall Official(s)
    • 01 Studienregister MasterAdmins, Study Director, UniversitaetsSpital Zuerich

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