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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02042456
• Other study ID #: 124.03-2013-GES-0003
• Status: Terminated
• Phase: N/A
• First received: January 20, 2014
• Last updated: October 16, 2015
• Start date: April 2014
• Est. completion date: July 2015

Study information

• Verified date: October 2015
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 124
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Digital Breast Tomosynthesis
digital breast tomosynthesis technology
• Automated Whole Breast Ultrasound
Automated Whole Breast Ultrasound
• Full Field Digital Mammography

Locations

Country	Name	City	State
United States	University of Washington Seattle Cancer Care Alliance	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Abnormal interpretation rate	Abnormal interpretation rates for each modality (FFDM and DBT+V-Preview, with and without ABUS+V-Preview).	One Year	No
Secondary	Sensitivity	Sensitivity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS	One Year	No
Secondary	Specificity	Specificity will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS	One Year	No
Secondary	Cancer Rate	Cancer Rate will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS	One Year	No
Secondary	Positive Predictive Value	Positive Predictive Value will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS	One Year	No
Secondary	Negative Predictive Value	Negative Predictive Value will be assessed for each imaging modality: FFDM and DBT+V-Preview, with and without ABUS	One Year	No