Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts
Stopped early
Conditions studied: Breast Cancer
In brief
This study is investigating whether automated whole breast ultrasound can improve detection of cancer in breast cancer screening when used as a supplement to mammography or as a supplement to digital breast tomosynthesis
Key facts
- Study ID
- NCT02042456
- Run by
- GE Healthcare
- People needed
- 124
- Starts
- 2014-04-01
- Expected to finish
- 2015-07-01
- Last updated by the study team
- 2015-10-20
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: accepted.
You may qualify if…
- Able and willing to provide signed declaration of informed consent or have a legally authorized representative provide signed declaration of informed consent for participation in all study procedures;
- Women aged ≥18 years at the time of enrollment;*
- Women with a previous determination of dense breasts determined by mammogram as heterogeneously dense or extremely dense;
- At moderately increased or high risk (>15% lifetime risk) for breast cancer based on meeting one or more of the ACS criteria 1:
- AND Referred for screening mammography
You may not qualify if…
- Have been screened using any breast imaging technology in <12 months immediately prior to enrollment;
- Exhibit breast cancer symptoms according to assessment by the subject's health care provider within one year prior to enrollment;
- Diagnosed with breast cancer, with or without metastasis, within one year prior to enrollment;
- Are currently pregnant as determined per standard clinical practice at the investigational site;
- Present with contraindications to any imaging examination required in the study protocol;
- Have breast implants; OR
- Are lactating.
Where it is running
- University of Washington Seattle Cancer Care Alliance — Seattle, Washington, United States
Full record on ClinicalTrials.gov
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