Breast Cancer
Conditions
Brief summary
The contribution of automated breast ultrasound (ABUS) to the screening pathway for breast cancer is not fully understood. This prospective study aims to collect longitudinal data in women with dense breasts undergoing ABUS as a supplement to digital breast tomosynthesis (DBT). The data are intended for use in future research on the value and effectiveness of ABUS in routine clinical care. Data will be collected from eligible women who have been prescribed or have completed DBT and ABUS, screening within a 30-day window. Radiologist evaluations and, when performed, outcomes of biopsy and/or laboratory testing will be recorded. Subjects will be followed for breast cancer status and results of any diagnostic breast exams and/or treatment.
Interventions
The ABUS system is designed to methodically scan a breast and capture multiple ultrasound images that can be rendered and reviewed in three dimensions.
Digital Breast Tomosynthesis (DBT) systems are designed to collect 3-dimensional x-ray images of breast tissues.
Sponsors
GE Healthcare
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Are asymptomatic adult women (aged 18 years or older); 2. Are eligible to complete or have completed (within 30 days) screening ABUS and DBT exams per the site standard of care;1 3. Have heterogeneously dense and extremely dense breasts (BI-RADS C or D, respectively) or are determined to have dense breasts prior to the study on initial screening mammography; 4. Are able and willing to participate.
Exclusion criteria
1\. Have a breast cancer diagnosis (with or without metastasis) or are being treated for breast cancer within the year prior to the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of Complete Breast Imaging Datasets | Up to 6 Years |
Secondary
| Measure | Time frame |
|---|---|
| Type of Exams Performed Per Patient | Up to 6 years |
| Breast Cancer Status | Up to 6 years |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Subjects All subjects will undergo scanning with both Automated Breast Ultrasound and Digital Breast Tomosynthesis devices.
Automated Breast Ultrasound: The ABUS system is designed to methodically scan a breast and capture multiple ultrasound images that can be rendered and reviewed in three dimensions.
Digital Breast Tomosynthesis: Digital Breast Tomosynthesis (DBT) systems are designed to collect 3-dimensional x-ray images of breast tissues. | 13 |
| Total | 13 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Physician Decision | 2 |
| Overall Study | Study Termination prior to follow-up | 11 |
Baseline characteristics
| Characteristic | All Subjects |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 13 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race/Ethnicity, Customized Race Black, African American, or Negro | 7 Participants |
| Race/Ethnicity, Customized Race Hispanic, Latino, or Spanish Origin | 1 Participants |
| Race/Ethnicity, Customized Race Other | 0 Participants |
| Race/Ethnicity, Customized Race White | 5 Participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 13 |
| other Total, other adverse events | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 |
Outcome results
Primary
Number of Complete Breast Imaging Datasets
Time frame: Up to 6 Years
Population: Study terminated prior to follow-up of any participants. No completed datasets were collected.
Secondary
Breast Cancer Status
Time frame: Up to 6 years
Population: 11 after withdrawals
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Subjects | Breast Cancer Status | Initial Diagnosis (Cancer) | 0 Subjects with findings |
| All Subjects | Breast Cancer Status | Initial Diagnosis (Non-Cancer) | 4 Subjects with findings |
Secondary
Type of Exams Performed Per Patient
Time frame: Up to 6 years
Population: All exams performed for enrolled subjects
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| All Subjects | Type of Exams Performed Per Patient | ABUS | 11 Exams completed |
| All Subjects | Type of Exams Performed Per Patient | DBT | 12 Exams completed |