CancerNCT01215318
FDG Uptake in Vaginal Tampons is Due to Urine
A study testing modified vaginal tampon in people with Cancer, run by Irene Burger at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 48 years, women only
- Conditions the study is for
- Cancer
- What is being tested?
- modified vaginal tampon
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 44 participants
- Where
- 1 siteSwitzerland
- Study dates
- 2 Feb 2010to 30 Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 48 years
- Women only
- No healthy volunteers
- Adult
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 locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Cancer
- Being tested
- modified vaginal tampon
- Keywords
- FDG PET/CT, vaginal tampon, urinary contamination, pitfall
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
modified vaginal tamponDevice
Also called Ob® Regular; Johnson & Johnson, with silicon seal
modified vaginal tampons versus unmodified vaginal tampons, comparing the urinary contamination
| Study group | Role | What they receive |
|---|---|---|
| Modified vaginal tampons | Experimental | Patients using modified vaginal tampons during FDG PET/CT Receives: Device: modified vaginal tampon |
| Unmodified vaginal tampons | Placebo comparator | Patients using unmodified vaginal tampons during FDG PET/CT Receives: Device: modified vaginal tampon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of FDG Positive Tampoons
Number of FDG positive Tampoons with an SUV > 3
Measured: 1 month
Secondary outcomes (1)
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.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study start2 Feb 2010
- Primary completion2 Aug 2010
- Study completion30 Sep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Irene Burger
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Irene Burger, University of Zurich
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215318
- Sponsor's protocol ID
- KEK-ZH-NR: 2010-0014
- Status last verified
- Aug 2019
- First submitted
- 4 Oct 2010
- Last updated
- 28 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01215318
- Acronym / sponsor ID
- KEK-ZH-NR: 2010-0014
- Conditions
- Cancer
- Keywords
- FDG PET/CT, vaginal tampon, urinary contamination, pitfall
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Irene BurgerUniversity, hospital or other
- Study start
- 2 Feb 2010 (actual)
- Primary completion
- 2 Aug 2010 (actual)
- Study completion
- 30 Sep 2010 (actual)
- First posted
- 6 Oct 2010 (estimated)
- Results
- Posted 28 Aug 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Modified vaginal tampons | Experimental | Device: modified vaginal tamponPatients using modified vaginal tampons during FDG PET/CT |
| Unmodified vaginal tampons | Placebo comparator | Device: modified vaginal tamponPatients using unmodified vaginal tampons during FDG PET/CT |
Who may qualify
- Ages
- 20 to 48 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| modified vaginal tamponAlso: Ob® Regular; Johnson & Johnson, with silicon sealmodified vaginal tampons versus unmodified vaginal tampons, comparing the urinary contamination | Device | Modified vaginal tampons, Unmodified vaginal tampons |
Primary outcome
Number of FDG Positive Tampoons
Time frame: 1 month
Number of FDG positive Tampoons with an SUV > 3
1 secondary outcome
Tampon Position Relative to the Pubococcygeal Line
Time frame: 1 month
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing modified vaginal tampon in people with Cancer, run by Irene Burger at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Aug 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of FDG Positive Tampoons (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2019.