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Test of Digital Breast Tomosynthesis vs. Common Mammography to Detect Breast Cancer for Women Undergoing Breast Biopsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GE Healthcare
ClinicalTrials.gov Identifier:
NCT00535184
First received: September 24, 2007
Last updated: March 21, 2012
Last verified: March 2012
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 3. Women Undergoing Breast Biopsy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GE Healthcare:

Enrollment: 220
Study Start Date: August 2007
Study Completion Date: February 2010
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
Detailed Description:

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.

  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 referrd for breast biopsy because of one or more abnormalities seen on routine screening mammography; who are also asymptomatic

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535184

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

No publications provided

Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT00535184     History of Changes
Other Study ID Numbers: GE 190-003
Study First Received: September 24, 2007
Last Updated: March 21, 2012
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 June 18, 2013