An observational study in Breast Cancer, sponsored by GE Healthcare. Terminated at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-09-09.
Sponsored by GE Healthcare · Observational
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.
This study will enroll adult women with dense breasts clinically referred for breast cancer screening.
Exclusion Criteria:
All subjects will undergo scanning with both Automated Breast Ultrasound and Digital Breast Tomosynthesis devices.
Device: Automated Breast Ultrasound · Device: Digital Breast Tomosynthesis
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.
Number of Complete Breast Imaging Datasets
Time frame: Up to 6 Years
Type of Exams Performed Per Patient
Time frame: Up to 6 years
Breast Cancer Status
Time frame: Up to 6 years
| Milestone | All Subjects |
|---|---|
| Started | 13 |
| Completed | 0 |
| Not completed | 13 |
| Withdrew: Study termination prior to follow-up | 11 |
| Withdrew: Physician decision | 2 |
No measurements were reported for this outcome.
| Exams completed | All Subjects |
|---|---|
| ABUS | 11 |
| DBT | 12 |
| Subjects with findings | All Subjects |
|---|---|
| Initial Diagnosis (Cancer) | 0 |
| Initial Diagnosis (Non-Cancer) | 4 |
Collected over 7 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Subjects | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Categorical(Participants) | All Subjects |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 13 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | All Subjects |
|---|---|
| Female | 13 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | All Subjects |
|---|---|
| Hispanic or Latino | 1 |
| Not Hispanic or Latino | 12 |
| Unknown or Not Reported | 0 |
| Race/Ethnicity, Customized(Participants) | All Subjects |
|---|---|
| Race — White | 5 |
| Race — Black, African American, or Negro | 7 |
| Race — Hispanic, Latino, or Spanish Origin | 1 |
| Race — Other | 0 |
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This study is terminated, as verified in Jul 2019. You cannot join it, but the record below documents what was studied.
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GE Healthcare