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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

September 24, 2007
March 21, 2012
August 2007
February 2010   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT00535184 on ClinicalTrials.gov Archive Site
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Test of Digital Breast Tomosynthesis vs. Common Mammography to Detect Breast Cancer for Women Undergoing Breast Biopsy
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
Comparison of the ability of DBT and FFDM to detect breast cancer.
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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample
Women referrd for breast biopsy because of one or more abnormalities seen on routine screening mammography; who are also asymptomatic
Breast Cancer
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
220
February 2010
February 2010   (final data collection date for primary outcome measure)

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
Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
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United States
 
NCT00535184
GE 190-003
No
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GE Healthcare
GE Healthcare
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Study Director: Amy Longcore GE Healthcare
GE Healthcare
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP