Trials / Completed
CompletedNCT00535184
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
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 220 (actual)
- Sponsor
- GE Healthcare · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Timeline
- Start date
- 2007-08-01
- Primary completion
- 2010-02-01
- Completion
- 2010-02-01
- First posted
- 2007-09-26
- Last updated
- 2012-03-22
Source: ClinicalTrials.gov record NCT00535184. Inclusion in this directory is not an endorsement.