Trial Outcomes & Findings for FDG Uptake in Vaginal Tampons is Due to Urine (NCT NCT01215318)

Results Overview

Number of FDG positive Tampoons with an SUV \> 3

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome timeframe

1 month

Results posted on

2019-08-28

Participant Flow

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.

Women with urogenital carcinoma were excluded.

Participant milestones

Participant milestones
Measure	Modified Vaginal Tampons Patients wearing modified tampons during PET/CT	Unmodified Vaginal Tampons Patients wearing unmodified vaginal tampons during FDG PET/CT
Overall Study STARTED	20	24
Overall Study COMPLETED	20	24
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

FDG Uptake in Vaginal Tampons is Due to Urine

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Modified Vaginal Tampons n=20 Participants Patients wearing modified vaginal tampons during PET/CT	Unmodified Vaginal Tampons n=24 Participants Patients wearing unmodified vaginal tampons during PET/CT	Total n=44 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Categorical Between 18 and 65 years	20 Participants n=39 Participants	24 Participants n=41 Participants	44 Participants n=35 Participants
Age, Categorical >=65 years	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Age, Continuous	39 years STANDARD_DEVIATION 7.7 • n=39 Participants	37 years STANDARD_DEVIATION 8.4 • n=41 Participants	39 years STANDARD_DEVIATION 8.5 • n=35 Participants
Sex: Female, Male Female	20 Participants n=39 Participants	24 Participants n=41 Participants	44 Participants n=35 Participants
Sex: Female, Male Male	0 Participants n=39 Participants	0 Participants n=41 Participants	0 Participants n=35 Participants
Region of Enrollment Switzerland	20 participants n=39 Participants	24 participants n=41 Participants	44 participants n=35 Participants

PRIMARY outcome

Timeframe: 1 month

Number of FDG positive Tampoons with an SUV \> 3

Outcome measures

Outcome measures
Measure	Modified Vaginal Tampons n=20 vaginal tampons Patients wearing modified tampons during FDG PET/CT	Unmodified Vaginal Tampons n=24 vaginal tampons Patients wearing unmodified tampons during FDG PET/CT
Number of FDG Positive Tampoons	2 FDG positive tampons	10 FDG positive tampons

SECONDARY outcome

Timeframe: 1 month

measure tampon position in regard to the pubococcygeal line to identify if positioning is responsible for urinary contamination.

Outcome measures

Outcome measures
Measure	Modified Vaginal Tampons n=20 vaginal tampons Patients wearing modified tampons during FDG PET/CT	Unmodified Vaginal Tampons n=24 vaginal tampons Patients wearing unmodified tampons during FDG PET/CT
Tampon Position Relative to the Pubococcygeal Line	5.9 mm Standard Deviation 17	5.1 mm Standard Deviation 11

Adverse Events

Modified Vaginal Tampons

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Unmodified Vaginal Tampons

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Irene A Burger

University Hospital of Zurich

Phone: +41 44 255 11 11

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place