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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Modified vaginal tampons | Experimental | Patients using modified vaginal tampons during FDG PET/CT |
|
| Unmodified vaginal tampons | Placebo Comparator | Patients using unmodified vaginal tampons during FDG PET/CT |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| modified vaginal tampon | Device | modified vaginal tampons versus unmodified vaginal tampons, comparing the urinary contamination |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of FDG Positive Tampoons | Number of FDG positive Tampoons with an SUV > 3 | 1 month |
| 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 |
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 01 Studienregister MasterAdmins | UniversitaetsSpital Zuerich | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital Zurich | Zurich | 8091 | Switzerland |
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Women with urogenital carcinoma were excluded.
Premenopausal women referred for FDG PET/CT examination for staging or follow up of malign disease, were given a modified or unmodified vaginal tampon during the PET/CT examination.
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| ID | Title | Description |
|---|---|---|
| FG000 | Modified Vaginal Tampons | Patients wearing modified tampons during PET/CT |
| FG001 | Unmodified Vaginal Tampons | Patients wearing unmodified vaginal tampons during FDG PET/CT |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Modified Vaginal Tampons | Patients wearing modified vaginal tampons during PET/CT |
| BG001 | Unmodified Vaginal Tampons | Patients wearing unmodified vaginal tampons during PET/CT |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of FDG Positive Tampoons | Number of FDG positive Tampoons with an SUV > 3 | Posted | Number | FDG positive tampons | 1 month | vaginal tampons | vaginal tampons |
|
|
During FDG PET/CT scan (2 hours)
Dyscomfort
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Modified Vaginal Tampons | Patients wearing modified vaginal tampon during PET/CT |
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absence of gynecological examination. Vaginal tampon position was only assessed with respect to the pubococcygeal line visualized on computer tomography.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Irene A Burger | University Hospital of Zurich | +41 44 255 11 11 | irene.burger@usz.ch |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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randomly assigned to either modified or unmodified tampons
|
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Participants |
|
| vaginal tampons |
|
|
| Secondary | 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. | Posted | Mean | Standard Deviation | mm | 1 month | vaginal tampons | vaginal tampons |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Unmodified Vaginal Tampons | Patients wearing unmodified vaginal tampon during PET/CT | 0 | 24 | 0 | 24 |
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