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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 1. Women Undergoing Screening Mammography


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 1. Women Undergoing Screening Mammography


Inclusion Criteria:



- Women ≥18 years or older for screening mammography

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

- The subject is 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

Outcome Measure:

Compare the diagnostic performance of FFDM and DBT in detecting and excluding breast cancer in asymptomatic women.

Principal Investigator

Amy Longcore

Investigator Role:

Study Director

Investigator Affiliation:

GE Healthcare

Authority:

United States: Food and Drug Administration

Study ID:

GE 190-001

NCT ID:

NCT00535678

Start Date:

June 2007

Completion Date:

July 2009

Related Keywords:

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

Name

Location

GE HealthcarePrinceton, New Jersey  08540