An Early Phase 1 interventional study of Digital Breast Tomosynthesis in Fibrocystic Disease of Breast and Breast Cancer, sponsored by Washington University School of Medicine. Completed at 1 site in United States. Open to female participants aged 35 Years to 80 Years. Per ClinicalTrials.gov, last updated 2015-06-02.
Sponsored by Washington University School of Medicine · Early Phase 1, Interventional, and Diagnostic
The purpose of this study is to compare conventional breast imaging and diagnostic work-up (2 dimensional imaging) to digital breast tomosynthesis (3 dimensional imaging) in the appearance of non-calcified breast masses. It is thought that non-calcified breast masses will be better visualized with the new 3D technology.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 136 is above the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Washington University School of Medicine is the lead sponsor of 1,765 studies on the registry; 271 are open to participants now.
Of its 324 completed or terminated interventional studies of FDA-regulated products, 212 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Observational
Device: Digital Breast Tomosynthesis
Women with a positive screening mammogram called back for additional views will be asked to undergo an additional Digital Breast Tomosynthesis (3D mammogram) on the affected breast. Radiation dose is somewhat less than that of a screening mammogram.
It is anticipated that out of 100 subjects recalled for additional breast imaging that 10 women will be recalled for biopsy. By adding 2D & 3D imaging, it is anticipated that 30 subjects out of 100 will have needed no workup.
Time frame: 9 months
This study is completed, as verified in Jun 2015. You cannot join it, but the record below documents what was studied.
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Washington University School of Medicine