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

Tracking Information
First Submitted Date	September 24, 2007
First Posted Date	September 26, 2007
Last Update Posted Date	March 22, 2012
Study Start Date	August 2007
Actual Primary Completion Date	February 2010 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures	Not Provided
Original Primary Outcome Measures	Not Provided
Change History	Complete list of historical versions of study NCT00535184 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures	Not Provided
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Test of Digital Breast Tomosynthesis vs. Common Mammography to Detect Breast Cancer for Women Undergoing Breast Biopsy
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
Brief Summary	Comparison of the ability of DBT and FFDM to detect breast cancer.
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.
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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
Condition	Breast Cancer
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: September 25, 2007)	220
Original Estimated Enrollment	Same as current
Actual Study Completion Date	February 2010
Actual Primary Completion Date	February 2010 (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender	Sexes Eligible for Study: Female
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	Not Provided
Removed Location Countries	United States
Administrative Information
NCT Number	NCT00535184
Other Study ID Numbers	GE 190-003
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	GE Healthcare
Study Sponsor	GE Healthcare
Collaborators	Not Provided
Investigators	Study Director: Amy Longcore GE Healthcare
PRS Account	GE Healthcare
Verification Date	March 2012