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Test of Digital Breast Tomosynthesis vs. Regular Mammography in Detecting Breast Cancer in Women Undergoing Diagnostic Mammography

This study has been completed.
Sponsor:
Information provided by:
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00535327
First received: September 24, 2007
Last updated: May 13, 2010
Last verified: May 2010
History of Changes
  Purpose

Comparison of the ability of DBT and FFDM to detect breast cancer.


Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Multicenter Study to Test Digital Breast Tomosynthesis (DBT) Compared to Full-Field Digital Mammography (FFDM) in Detecting Breast Cancer. Part 2. Women Undergoing Diagnostic Mammography

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GE Healthcare:

Estimated Enrollment: 220
Study Start Date: August 2007
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Women referred for diagnostic mammogram

Criteria

Inclusion Criteria:

  • Women ≥18 years or older and has underwent screening mammography and is now referred for diagnostic mammography
  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535327

Sponsors and Collaborators
GE Healthcare
Investigators
Study Director: Amy Longcore GE Healthcare
  More Information

No publications provided

Responsible Party: GE Healthcare - Kevin Horgan, GE Healthcare
ClinicalTrials.gov Identifier: NCT00535327     History of Changes
Other Study ID Numbers: GE 190-002
Study First Received: September 24, 2007
Last Updated: May 13, 2010
Health Authority: United States: Food and Drug Administration
Canada: Health Canada

Keywords provided by GE Healthcare:
Mammography
mammogram
breast
Abnormal and normal breast tissue

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 21, 2013