NCT01215318

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable cancer

Timeline
Completed

Started Feb 2010

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2010

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 2, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2010

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

October 4, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 6, 2010

Completed
8.9 years until next milestone

Results Posted

Study results publicly available

August 28, 2019

Completed
Last Updated

August 28, 2019

Status Verified

August 1, 2019

Enrollment Period

6 months

First QC Date

October 4, 2010

Results QC Date

October 8, 2010

Last Update Submit

August 14, 2019

Conditions

Cancer

Keywords

FDG PET/CT, vaginal tampon, urinary contamination, pitfall

Outcome Measures

Primary Outcomes (1)

  • Number of FDG Positive Tampoons

    Number of FDG positive Tampoons with an SUV \> 3

    1 month

Secondary Outcomes (1)

  • Tampon Position Relative to the Pubococcygeal Line

    1 month

Study Arms (2)

Modified vaginal tampons

EXPERIMENTAL

Patients using modified vaginal tampons during FDG PET/CT

Device: modified vaginal tampon

Unmodified vaginal tampons

PLACEBO COMPARATOR

Patients using unmodified vaginal tampons during FDG PET/CT

Device: modified vaginal tampon

Interventions

modified vaginal tamponDEVICE

modified vaginal tampons versus unmodified vaginal tampons, comparing the urinary contamination

Also known as: Ob® Regular; Johnson & Johnson, with silicon seal
Modified vaginal tamponsUnmodified vaginal tampons

Eligibility Criteria

Age20 Years - 48 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich

Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Neoplasms

Limitations and Caveats

absence of gynecological examination. Vaginal tampon position was only assessed with respect to the pubococcygeal line visualized on computer tomography.

Results Point of Contact

Title
Irene A Burger
Organization
University Hospital of Zurich
irene.burger@usz.ch
+41 44 255 11 11

Study Officials

  • 01 Studienregister MasterAdmins

    UniversitaetsSpital Zuerich

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Masking Details
randomly assigned to either modified or unmodified tampons
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Attending physician

Study Record Dates

First Submitted

October 4, 2010

First Posted

October 6, 2010

Study Start

February 2, 2010

Primary Completion

August 2, 2010

Study Completion

September 30, 2010

Last Updated

August 28, 2019

Results First Posted

August 28, 2019

Record last verified: 2019-08

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)