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OpenTrials
Completed

NCT Number: NCT01215318

FDG Uptake in Vaginal Tampons is Due to Urine

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.

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Key information

Conditions

Cancer Neoplasms

Age range

20 year–48 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich

Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

modified vaginal tampon

Device

modified vaginal tampons versus unmodified vaginal tampons, comparing the urinary contamination

Other names: Ob® Regular; Johnson & Johnson, with silicon seal

Primary outcomes

  1. Number of FDG Positive Tampoons

    Time frame: 1 month

    Number of FDG positive Tampoons with an SUV > 3

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Irene Burger

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Oct 6, 2010
Registry last updated
Aug 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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