Automated Breast Ultrasound as an Adjunct to Screening Digital Breast Tomosynthesis

NCT ID: NCT03616457

Last Updated: 2018-10-26

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-08-31
• Study Completion Date: 2021-08-31

Brief Summary

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.

Detailed Description

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

All Study Participants

All study participants will undergo the same study procedures, including Automated Breast Ultrasound (ABUS).

Automated Breast Ultrasound (ABUS)

Intervention Type: DEVICE

Participants will undergo imaging with ABUS.

Interventions

Automated Breast Ultrasound (ABUS)

Participants will undergo imaging with ABUS.

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Georgia Spear

Role: PRINCIPAL_INVESTIGATOR

Endeavor Health

Other Identifiers

110.01-2018-GES-0001

Identifier Type: -

Identifier Source: org_study_id