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NCT01215318 · REGISTRY CONDITION SEARCH

FDG Uptake in Vaginal Tampons is Due to Urine

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
NA
Status at capture
COMPLETED
Registry last update
2019-08-28

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Number of FDG Positive Tampoons

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outcome · POSTED

Tampon Position Relative to the Pubococcygeal Line

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
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.
healthy Volunteers
false
maximum Age
48 Years
minimum Age
20 Years
sex
FEMALE
std Ages
  1. ADULT
Treatment arms and interventions
arm Groups
  1. description
    Patients using modified vaginal tampons during FDG PET/CT
    intervention Names
    1. Device: modified vaginal tampon
    label
    Modified vaginal tampons
    type
    EXPERIMENTAL
  2. description
    Patients using unmodified vaginal tampons during FDG PET/CT
    intervention Names
    1. Device: modified vaginal tampon
    label
    Unmodified vaginal tampons
    type
    PLACEBO_COMPARATOR
interventions
  1. arm Group Labels
    1. Modified vaginal tampons
    2. Unmodified vaginal tampons
    description
    modified vaginal tampons versus unmodified vaginal tampons, comparing the urinary contamination
    name
    modified vaginal tampon
    other Names
    1. Ob® Regular; Johnson & Johnson, with silicon seal
    type
    DEVICE
Study design
allocation
RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
DOUBLE
masking Description
randomly assigned to either modified or unmodified tampons
who Masked
  1. PARTICIPANT
  2. INVESTIGATOR
primary Purpose
DIAGNOSTIC
Enrollment
count
44
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Number of FDG positive Tampoons with an SUV \> 3
    measure
    Number of FDG Positive Tampoons
    time Frame
    1 month
secondary Outcomes
  1. description
    measure tampon position in regard to the pubococcygeal line to identify if positioning is responsible for urinary contamination.
    measure
    Tampon Position Relative to the Pubococcygeal Line
    time Frame
    1 month
Full study description
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.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-f8726a2b8a6a83422160
      requested nct id
      NCT01215318
      primary nct id
      NCT01215318
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      b6710ff985346052b92134d475e1f6f9b2a9bbb7c87d1a3d83093a5921deff50
      payload sha256
      f53a7e87eff8f3cb0b2981e34aac0e06a74d678cbe999fb30214794dbf18aa45
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-f8726a2b8a6a83422160
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT01215318
      occurrences
      1. context exact
        NCT01215318
        end
        11
        exact text
        NCT01215318
        start
        0
      offset unit
      unicode_code_points
      query cond
      Vaginal Cancer
      query disease state id
      ds-vaginal-cancer
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-vaginal-cancer-000.json
      source file sha256
      b6710ff985346052b92134d475e1f6f9b2a9bbb7c87d1a3d83093a5921deff50
      source json pointer
      /studies/54/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      e6bd1adf3248d8fd717f34249d0764112a14ef2b6c8f21655509226359542560

    Preserved source evidence · Not medical advice