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

Study Overview
=================
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

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

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: Digital Breast Tomosynthesis
* Device: Automated Whole Breast Ultrasound
* Device: Full Field Digital Mammography


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Main Cohort<br>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. | Device: Digital Breast Tomosynthesis<br>* digital breast tomosynthesis technology<br>* Other names: GE SenoClaire DBT with V-Preview;Device: Automated Whole Breast Ultrasound<br>* Automated Whole Breast Ultrasound<br>* Other names: Invenia ABUS;Device: Full Field Digital Mammography<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abnormal interpretation rate | Abnormal interpretation rates for each modality (FFDM and DBT+V-Preview, with and without ABUS+V-Preview). | One Year | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breast cancer, dense breasts, mammography screening, Screening techniques, women