Automated Breast Ultrasound and Digital Breast Tomosynthesis Screening Compared to Full Field Digital Mammography in Women With Dense Breasts

Terminated

• Conditions: Breast Cancer

• Registration Number: NCT02042456
• Lead Sponsor: GE Healthcare

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-20
• Study First Submitted QC: 2014-01-21
• Study First Posted: 2014-01-22
• Study Start: 2014-04
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-16
• Last Update Posted: 2015-10-20

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 124

Inclusion Criteria

• 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

Exclusion Criteria

• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Abnormal interpretation rate	One Year	Abnormal interpretation rates for each modality (FFDM and DBT+V-Preview, with and without ABUS+V-Preview).

Secondary Outcome Measures

Name	Time	Method
Sensitivity	One Year	Sensitivity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS
Specificity	One Year	Specificity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS
Cancer Rate	One Year	Cancer Rate will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS
Positive Predictive Value	One Year	Positive Predictive Value will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS
Negative Predictive Value	One Year	Negative Predictive Value will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS

Trial Locations

Locations (1)

University of Washington Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States