Acquisition of Breast Mammography Images

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Fujifilm Medical Systems USA, Inc.
ClinicalTrials.gov Identifier:
NCT02156258
First received: June 2, 2014
Last updated: February 1, 2016
Last verified: February 2016
  Purpose
This is a case collection study of breast images using standard and new mammography technology.

Condition Intervention Phase
Breast Cancer
Device: FFDM Mammography
Device: DBT Mammography
Phase 3

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Acquisition of Digital Mammography and Breast Images for Clinical Evaluation of FujifilmDigital Breast Tomosynthesis

Resource links provided by NLM:


Further study details as provided by Fujifilm Medical Systems USA, Inc.:

Primary Outcome Measures:
  • 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 ]

Enrollment: 1232
Study Start Date: June 2014
Estimated Study Completion Date: December 2016
Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Cancer Cases
Collection of cancer cases using Full Field Digital Mammography (FFDM) Mammography and Digital Breast Tomosynthesis (DBT) Mammography
Device: FFDM Mammography
Standard mammography image collection
Device: DBT Mammography
Collection of breast images using DBT mammography
Recall Cases
Collection of Imaging Recall Cases using FFDM Mammography and DBT Mammography
Device: FFDM Mammography
Standard mammography image collection
Device: DBT Mammography
Collection of breast images using DBT mammography
Non-Cancer Cases
Collection of Non-Cancer Cases using FFDM Mammography and DBT Mammography
Device: FFDM Mammography
Standard mammography image collection
Device: DBT Mammography
Collection of breast images using DBT mammography

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
A total of at least 200 cancer, 175 recall cases and 350 negative/benign cases will be accumulated
Criteria

Inclusion Criteria:

For Screening Subjects

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

For Recall Subjects

  • Be at least 18 years of age,
  • Received a BIRADS 0 within the last 60 days
  • Are recalled for additional imaging

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02156258

Locations
United States, Arizona
Scottsdale Medical Imaging, Ltd
Scottsadale, Arizona, United States, 85258
United States, Iowa
University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States, 52242
United States, New York
Elizabeth Wende Breast Care, LLC
Rochester, New York, United States, 14620
United States, North Carolina
University of North Carolina - at Chapel Hill
Chapel Hill, North Carolina, United States, 27599
United States, Texas
University of Texas Health Science Center at San Antonio
San Antonio, Texas, United States, 78229
Sponsors and Collaborators
Fujifilm Medical Systems USA, Inc.
Investigators
Principal Investigator: Etta D Pissano, MD Medical University of South Carolina
  More Information

Responsible Party: Fujifilm Medical Systems USA, Inc.
ClinicalTrials.gov Identifier: NCT02156258     History of Changes
Other Study ID Numbers: FMSU2013-004A 
Study First Received: June 2, 2014
Last Updated: February 1, 2016
Health Authority: United States: Food and Drug Administration

Keywords provided by Fujifilm Medical Systems USA, Inc.:
Imaging
Mammography

ClinicalTrials.gov processed this record on August 28, 2016