FDG Uptake in Vaginal Tampons is Due to Urine

Study Overview
=================
Brief Summary
-----------------
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.

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.

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

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Device: modified vaginal tampon


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 48 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Modified vaginal tampons<br>Patients using modified vaginal tampons during FDG PET/CT | Device: modified vaginal tampon<br>* modified vaginal tampons versus unmodified vaginal tampons, comparing the urinary contamination<br>* Other names: Ob® Regular; Johnson & Johnson, with silicon seal;|
| Placebo Comparator: Unmodified vaginal tampons<br>Patients using unmodified vaginal tampons during FDG PET/CT | Device: modified vaginal tampon<br>* modified vaginal tampons versus unmodified vaginal tampons, comparing the urinary contamination<br>* 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 | 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 | measure tampon position in regard to the pubococcygeal line to identify if positioning is responsible for urinary contamination. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FDG PET/CT, vaginal tampon, urinary contamination, pitfall