FDG Uptake in Vaginal Tampons is Due to Urine

August 14, 2019 updated by: Irene Burger

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zurich, Switzerland, 8091
        • University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 48 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Modified vaginal tampons
Patients using modified vaginal tampons during FDG PET/CT
Device: modified vaginal tampon
modified vaginal tampons versus unmodified vaginal tampons, comparing the urinary contamination
Other Names:
  • Ob® Regular; Johnson & Johnson, with silicon seal
PLACEBO_COMPARATOR: Unmodified vaginal tampons
Patients using unmodified vaginal tampons during FDG PET/CT
Device: modified vaginal tampon
modified vaginal tampons versus unmodified vaginal tampons, comparing the urinary contamination
Other Names:
  • Ob® Regular; Johnson & Johnson, with silicon seal

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Irene Burger

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 2, 2010

Primary Completion (ACTUAL)

August 2, 2010

Study Completion (ACTUAL)

September 30, 2010

Study Registration Dates

First Submitted

October 4, 2010

First Submitted That Met QC Criteria

October 4, 2010

First Posted (ESTIMATE)

October 6, 2010

Study Record Updates

Last Update Posted (ACTUAL)

August 28, 2019

Last Update Submitted That Met QC Criteria

August 14, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KEK-ZH-NR: 2010-0014

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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