Test of Digital Breast Tomosynthesis vs. Common Mammography to Detect Breast Cancer for Women Undergoing Breast Biopsy
This study has been completed.
Information provided by (Responsible Party):
First received: September 24, 2007
Last updated: March 21, 2012
Last verified: March 2012
Comparison of the ability of DBT and FFDM to detect breast cancer.
||Observational Model: Cohort
Time Perspective: Prospective
||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
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||February 2010 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||18 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
Women referrd for breast biopsy because of one or more abnormalities seen on routine screening mammography; who are also asymptomatic
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00535184
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 24, 2007
||March 21, 2012
||United States: Food and Drug Administration
Canada: Health Canada
Keywords provided by GE Healthcare:
ClinicalTrials.gov processed this record on March 30, 2015
Abnormal and normal breast tissue