Automated Breast Ultrasound as an Adjunct to Screening Digital Breast Tomosynthesis

Breast Cancer Clinical Trial

— AMELIA  

Official title:

Evaluation of Automated Breast Ultrasound as an Adjunct to Screening Digital Breast Tomosynthesis in Women With Dense Breasts (AMELIA)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03616457
• Other study ID #: 110.01-2018-GES-0001
• Status: Withdrawn
• Start date: August 2018
• Est. completion date: August 2021

Study information

• Verified date: October 2018
• Source: GE Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: August 2021
• Est. primary completion date: August 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Automated Breast Ultrasound (ABUS)
Participants will undergo imaging with ABUS.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
GE Healthcare

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer Detection Rate	Cancer detection rate of DBT plus ABUS and DBT alone	up to 16 months
Secondary	Invasive Cancer Detection	To demonstrate DBT plus ABUS has non-inferior invasive cancer detection relative to DBT alone in women with dense breasts	up to 16 months
Secondary	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.	up to 16 months
Secondary	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.	up to 16 months