Clinical trial NCT03616457: Automated Breast Ultrasound as an Adjunct to Screening Digital Breast Tomosynthesis
Official title: Evaluation of Automated Breast Ultrasound as an Adjunct to Screening Digital Breast Tomosynthesis in Women With Dense Breasts (AMELIA)
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Breast Cancer
Keywords: Screening Diagnostic
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2018-08-06
Enrollment: 0
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This study will enroll asymptomatic adults who are clinically referred for breast cancer screening. Participants in this study will be representative of the clinical population.

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.

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.

Primary outcomes:
measure: Cancer Detection Rate
timeFrame: up to 16 months
Secondary outcomes:
measure: Invasive Cancer Detection
timeFrame: up to 16 months
measure: Positive Predictive Value
timeFrame: up to 16 months
measure: Recall Rates
timeFrame: up to 16 months
Other outcomes:
Locations:
Study officials:
affiliation: Endeavor Health
name: Georgia Spear
role: PRINCIPAL_INVESTIGATOR
References: