Clinical trial · Observational
Automated Breast Ultrasound as an Adjunct to Screening Digital Breast Tomosynthesis
Evaluation of Automated Breast Ultrasound as an Adjunct to Screening Digital Breast Tomosynthesis in Women With Dense Breasts (AMELIA)
- 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 need.
Summary
Brief summary (as posted)
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.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Automated Breast Ultrasound (ABUS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- All Study Participants
- description
- All study participants will undergo the same study procedures, including Automated Breast Ultrasound (ABUS).
- interventionNames
- Device: Automated Breast Ultrasound (ABUS)
Primary outcomes (1)
- measure
- Cancer Detection Rate
- timeFrame
- up to 16 months
- description
- Cancer detection rate of DBT plus ABUS and DBT alone
Secondary outcomes (3)
- measure
- Invasive Cancer Detection
- timeFrame
- up to 16 months
- description
- To demonstrate DBT plus ABUS has non-inferior invasive cancer detection relative to DBT alone in women with dense breasts
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available