Automated Breast Ultrasound as an Adjunct to Screening Digital Breast Tomosynthesis

GE Healthcare

Overview

The purpose of this study is to assess whether the Invenia™ Automated Breast Ultrasound (ABUS) device, as an adjunct to Digital Breast Tomosynthesis (DBT), improves breast cancer detection in women with dense breasts. The study aims to collect information about cancer detection, treatment, and outcomes based on individual and combined technologies in patients who receive ABUS exams in addition to DBT. The results of this study are intended to be used to extend understanding of ABUS as an adjunct in DBT screening in patients with dense breasts.

Following consenting procedures, subjects will undergo standard of care DBT of both breasts or of one breast if they have had prior uni-lateral mastectomy. Subjects will also undergo ABUS of both breasts or of one breast if they have had prior uni-lateral mastectomy. These imaging exams will be done per the sites routine practice, and can be done in any order. Images will be read and assessed by one (1) Mammography Quality Standards Act (MQSA)-qualified reader. The evaluating radiologist will use the image reconstruction views appropriate for the evaluation, per his or her medical judgment, and handle diagnostic evaluations in accordance with the standard of care at the investigational site. The DBT images will be read and assessed first and independent of ABUS images. DBT plus ABUS will then be read per routine practice and assessed. Images will not be read until both imaging exams have been completed. If screening shows a suspicious finding, subjects will receive standard of care follow-up and appropriate workup, which may include biopsy (as needed), to determine cancer status. Subjects will be followed at approximately one year (11- to 16-months) unless negative histopathology with image concordance or positive cancer status is histologically determined prior to one-year follow-up. Follow up procedures will be conducted as per the sites standard of care.

Study Type

OBSERVATIONAL

Conditions

Breast Cancer

Interventions

Automated Breast Ultrasound (ABUS)DEVICE

Participants will undergo imaging with ABUS.

Eligibility

Sex: FEMALEMin age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Are asymptomatic adult women (aged 40 years or older); 2. Are presenting for a DBT breast cancer screening exam; 3. Have heterogeneously dense or extremely dense breasts (BI-RADS C or D) 4. Are able and willing to participate. Exclusion Criteria: 1. Have been previously included in this study; 2. Have undergone diagnostic or surgical intervention in the last 12 months, including, but not limited to, core or open biopsy, clip placement, fine-needle aspiration, cytopunction, breast reduction or reconstruction, implant removals; OR 3. Have had a breast cancer diagnosis or treatment in the past 12 months and have re-entered the screening population.

Outcomes

Primary Outcomes

Cancer Detection Rate

Cancer detection rate of DBT plus ABUS and DBT alone

Time frame: up to 16 months

Secondary Outcomes

Invasive Cancer Detection

To demonstrate DBT plus ABUS has non-inferior invasive cancer detection relative to DBT alone in women with dense breasts

Time frame: up to 16 months

Positive Predictive Value

To demonstrate DBT plus ABUS has non-inferior positive predictive value (PPV 1) for breast cancer relative to DBT alone in women with dense breasts.

Time frame: up to 16 months

Recall Rates

To summarize recall rate of DBT plus ABUS in relation to the recall rate of DBT alone for breast cancer screening in dense breasts.

Time frame: up to 16 months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.