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Acquisition of Breast Mammography Images

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2014 by Fujifilm Medical Systems USA, Inc.
Sponsor:
Information provided by (Responsible Party):
Fujifilm Medical Systems USA, Inc.
ClinicalTrials.gov Identifier:
NCT02156258
First received: June 2, 2014
Last updated: November 13, 2014
Last verified: November 2014

June 2, 2014
November 13, 2014
June 2014
March 2016   (final data collection date for primary outcome measure)
  • Case Collection of Mammography Images with Breast Cancer [ Time Frame: 20 Months ] [ Designated as safety issue: No ]
  • Case Collection of Mammography Images that Required Recall with No Cancer [ Time Frame: 20 Months ] [ Designated as safety issue: No ]
  • Case Collection of Mammography Images with No Cancer [ Time Frame: 20 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT02156258 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Acquisition of Breast Mammography Images
Acquisition of Digital Mammography and Breast Images for Clinical Evaluation of FujifilmDigital Breast Tomosynthesis

This is a case collection study of breast images using standard and new mammography technology.

This image acquisition study is designed to acquire the study image data and establish and document the clinical findings for each subject. This study will create a library of image data that will be used for future projects.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample

A total of at least 200 cancer, 175 recall cases and 350 negative/benign cases will be accumulated

Breast Cancer
  • Device: FFDM Mammography
    Standard mammography image collection
  • Device: DBT Mammography
    Collection of breast images using DBT mammography
  • Cancer Cases
    Collection of cancer cases using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography
    Interventions:
    • Device: FFDM Mammography
    • Device: DBT Mammography
  • Recall Cases
    Collection of Imaging Recall Cases using FFDM Mammography and DBT Mammography
    Interventions:
    • Device: FFDM Mammography
    • Device: DBT Mammography
  • Non-Cancer Cases
    Collection of Non-Cancer Cases using FFDM Mammography and DBT Mammography
    Interventions:
    • Device: FFDM Mammography
    • Device: DBT Mammography
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1600
March 2016
March 2016   (final data collection date for primary outcome measure)

Inclusion Criteria:

For Screening Subjects

  • Be at least 40 years of age, are
  • Asymptomatic,
  • Scheduled for a routine screening mammogram

For Diagnostic Subjects

  • Be at least 18 years of age,
  • Scheduled for a biopsy due to an assessment of Breast Imaging and Reporting Data (BI-RADS®) 4 or 5 after diagnostic work-up of a suspicious screening or clinical finding within the last 60 days.
  • Understand requirements and willing to participate in study

Exclusion Criteria:

  • Presence of a breast implant.
  • Women with only a single breast; for example, post mastectomy patients.
  • Is pregnant or believes she may be pregnant.
  • A woman who has delivered and who has expressed the intention to breast-feed or is currently breast-feeding.
  • A woman who has significant existing breast trauma within the last one year.
  • Have self-reported severe non-focal or bilateral breast pain affecting subject's ability to tolerate digital mammography and/or breast tomosynthesis examinations.
  • A woman who has had a mammogram performed for the purpose of therapy portal planning within the last year.
  • Cannot, for any known reason, undergo follow-up digital mammography and/or breast tomosynthesis examinations (where clinically indicated) at the participating institution.
  • Is an inmate (see US Code of Federal Regulations 45CFR46.306).
Female
18 Years and older
Yes
Contact: Jesse Lin, PhD 301.251.992 jlin@fujifilm.com
United States
 
NCT02156258
FMSU2013-004A
No
Fujifilm Medical Systems USA, Inc.
Fujifilm Medical Systems USA, Inc.
Not Provided
Principal Investigator: Etta D Pissano, MD Medical University of South Carolina
Fujifilm Medical Systems USA, Inc.
November 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP