Clinical trial · Observational
Automated Breast Ultrasound Case Collection Registry
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Change in business strategy
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Automated Breast Ultrasound | Device | — | UNRESOLVED |
| Digital Breast Tomosynthesis | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All Subjects
- description
- All subjects will undergo scanning with both Automated Breast Ultrasound and Digital Breast Tomosynthesis devices.
- interventionNames
- Device: Automated Breast Ultrasound
- Device: Digital Breast Tomosynthesis
Primary outcomes (1)
- measure
- Number of Complete Breast Imaging Datasets
- timeFrame
- Up to 6 Years
Secondary outcomes (2)
- measure
- Type of Exams Performed Per Patient
- timeFrame
- Up to 6 years
- measure
- Breast Cancer Status
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available