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

Terminated

• Conditions: Breast Cancer
• Interventions: Device: Digital Breast Tomosynthesis; Device: Automated Whole Breast Ultrasound; Device: Full Field Digital Mammography

• 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

Arm && Interventions

Group	Intervention	Description
Main Cohort	Digital Breast Tomosynthesis	Subjects enrolled in this group will receive a full field digital mammogram, digital breast tomosynthesis exam and an automated whole breast ultrasound exam as part of their visit.
Main Cohort	Automated Whole Breast Ultrasound	Subjects enrolled in this group will receive a full field digital mammogram, digital breast tomosynthesis exam and an automated whole breast ultrasound exam as part of their visit.
Main Cohort	Full Field Digital Mammography	Subjects enrolled in this group will receive a full field digital mammogram, digital breast tomosynthesis exam and an automated whole breast ultrasound exam as part of their visit.

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