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FDG Uptake in Vaginal Tampons is Due to Urine

I

Irene Burger

Status

Completed

Conditions

Cancer

Treatments

Device: modified vaginal tampon

Study type

Interventional

Funder types

Other

Identifiers

NCT01215318
KEK-ZH-NR: 2010-0014

Details and patient eligibility

About

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 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.

Enrollment

44 patients

Sex

Female

Ages

20 to 48 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Diagnostic

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

44 participants in 2 patient groups, including a placebo group

Modified vaginal tampons
Experimental group
Description:
Patients using modified vaginal tampons during FDG PET/CT
Treatment:
Device: modified vaginal tampon
Unmodified vaginal tampons
Placebo Comparator group
Description:
Patients using unmodified vaginal tampons during FDG PET/CT
Treatment:
Device: modified vaginal tampon

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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