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A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 3. Women Undergoing Breast Biopsy


N/A
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 3. Women Undergoing Breast Biopsy


Enrolled women will undergo bilateral DBT. Prior breast imaging data (screening and
diagnostic mammography) must have been conducted on GE equipment and the images must be
available (or imaging must be repeated). DBT images will be read on-site by one or more
qualified radiologists. All subjects who undergo biopsy will be asked to return in
approximately 1 year for a follow-up mammogram. Images will be processed and evaluated by
independent readers.


Inclusion Criteria:



- Women ≥18 years or older and has underwent screening/diagnostic mammography and
referred for breast biopsy

- Able and willing to comply with study procedures, and have signed and dated the
informed consent form

- Surgically sterile or postmenopausal

Exclusion Criteria:

- Pregnant or trying to become pregnant

- Has signs or symptoms of breast cancer

- Has been previously included in this study

- Has breast implants

- Has a history of breast cancer and is in active treatment

- Has breasts too large to be adequately positioned for the DBT examination

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Principal Investigator

Amy Longcore

Investigator Role:

Study Director

Investigator Affiliation:

GE Healthcare

Authority:

United States: Food and Drug Administration

Study ID:

GE 190-003

NCT ID:

NCT00535184

Start Date:

August 2007

Completion Date:

February 2010

Related Keywords:

  • Breast Cancer
  • Mammography
  • mammogram
  • breast
  • Abnormal and normal breast tissue
  • Breast Neoplasms

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