Cancer
Conditions
Keywords
FDG PET/CT, vaginal tampon, urinary contamination, pitfall
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.
Interventions
DEVICEmodified vaginal tampon
modified vaginal tampons versus unmodified vaginal tampons, comparing the urinary contamination
Sponsors
Irene Burger
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
DOUBLE (Subject, Investigator)
Masking description
randomly assigned to either modified or unmodified tampons
Eligibility
Sex/Gender
FEMALE
Age
20 Years to 48 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of FDG Positive Tampoons | 1 month | Number of FDG positive Tampoons with an SUV \> 3 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tampon Position Relative to the Pubococcygeal Line | 1 month | measure tampon position in regard to the pubococcygeal line to identify if positioning is responsible for urinary contamination. |
Countries
Switzerland
Participant flow
Recruitment details
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.
Pre-assignment details
Women with urogenital carcinoma were excluded.
Participants by arm
| Arm | Count |
|---|---|
| Modified Vaginal Tampons Patients wearing modified vaginal tampons during PET/CT | 20 |
| Unmodified Vaginal Tampons Patients wearing unmodified vaginal tampons during PET/CT | 24 |
| Total | 44 |
Baseline characteristics
| Characteristic | Unmodified Vaginal Tampons | Modified Vaginal Tampons | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants | 20 Participants | 44 Participants |
| Age, Continuous | 37 years STANDARD_DEVIATION 8.4 | 39 years STANDARD_DEVIATION 7.7 | 39 years STANDARD_DEVIATION 8.5 |
| Region of Enrollment Switzerland | 24 participants | 20 participants | 44 participants |
| Sex: Female, Male Female | 24 Participants | 20 Participants | 44 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 20 | 0 / 24 |
| serious Total, serious adverse events | 0 / 20 | 0 / 24 |
Outcome results
Primary
Number of FDG Positive Tampoons
Number of FDG positive Tampoons with an SUV \> 3
Time frame: 1 month
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Modified Vaginal Tampons | Number of FDG Positive Tampoons | 2 FDG positive tampons |
| Unmodified Vaginal Tampons | Number of FDG Positive Tampoons | 10 FDG positive 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.
Time frame: 1 month
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Modified Vaginal Tampons | Tampon Position Relative to the Pubococcygeal Line | 5.9 mm | Standard Deviation 17 |
| Unmodified Vaginal Tampons | Tampon Position Relative to the Pubococcygeal Line | 5.1 mm | Standard Deviation 11 |