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SCCA Breast Cancer Clinical Trials

Screening Tomosynthesis and Automated Breast Ultrasound Research (STAR-8159)
Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts
Status Conditions Phase Study ID
Recruiting Women with dense breasts and risk of breast cancer (see below). N/A 8159
NCT02042456
Summary

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.

 


Investigator
Constance Lehman, MD
Location    
Seattle Cancer Care Alliance (206) 288-6321  
Eligibility Criteria (must meet the following to participate in this study)
  • 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; AND
  • At moderately increased or high risk (>15% lifetime risk) for breast cancer based on meeting one or more of the ACS criteria 1:
    1. BRCA1 or BRCA2 gene mutation;
    2. First-degree relative with BRCA1 or BRCA2 gene mutation (based on subject self-report) and have not had genetic testing themselves;
    3. Radiation therapy to the chest between ages 10 and 30 years;
    4. Li-Fraumeni syndrome, Cowden syndrome, or Bannayan-Riley-Ruvalcaba syndrome, or one of these syndromes in a first-degree relative;
    5. Previous diagnosis of breast cancer, ductal carcinoma in situ (DCIS), lobular carcinoma in situ, atypical ductal hyperplasia, or atypical lobular hyperplasia.
Exclusions (conditions that would prevent participation in this study)
  • 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 based on urine pregnancy test;*
  • Present with contraindications to any imaging examination required in the study protocol;
  • Have breast implants;
  • Are lactating.
Last Updated
October 09, 2014
See this trial at ClinicalTrials.gov
Access protocol and consent forms at Fred Hutchinson Cancer Research Center
Disclaimer: We update this information regularly. However, what you read today may not be completely up to date.

Please remember:
  • Talk to your health care providers first before making decisions about your health care.
  • Whether you are eligible for a research study depends on many things. There are specific requirements to be in research studies. These requirements are different for each study.