Clinical trial · Observational
Diagnostic Performance of an Automated Breast Ultrasound System (ABUS)
Diagnostic Performance of an Automated Breast Ultrasound System (ABUS): a Single Centre Study
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the diagnostic performance of a new ABUS system among 4 different population: Population A: women undergoing screening for familial or genetic predisposition for breast cancer. Population B: women with newly diagnosed breast cancer. ABUS performance will be compared to breast MRI in the pre-operative assessment of breast cancer extent. Population C: women with BI-RADS 3 or 4 lesions in a routine breast imaging examination. ABUS will be evaluate as a problem-solving tool. Population D: women undergoing breast MRI for the assessment of breast implants integrity. ABUS performance will be compared to breast MRI.
Conditions
Conditions (2)
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 |
| Implants | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Automated breast ultrasound examination (ABUS) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Population A
- description
- Consecutive women in the age range 20 to 40 years, with a strong family history of breast cancer or a predisposing gene mutation such as BRCA1 or BRCA2, referring to our department for breast evaluation with ultrasound, will be invited to participate to the study. During the interview, before imaging examination, women will be questioned about family history as well as other relevant personal information (e.g. previous surgery or biopsy for benign breast disease).
- interventionNames
- Device: Automated breast ultrasound examination (ABUS)
- label
- Population B
- description
- Consecutive women with a new breast cancer diagnosis and undergoing pre-operative MRI examination for local staging will be invited to participate to the study. ABUS will be performed within two weeks before the scheduled surgery.
- interventionNames
- Device: Automated breast ultrasound examination (ABUS)
- label
- Population C
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Population A - Inclusion criteria: * Age between 20 and 40 years * family history of breast cancer or a proved predisposing gene mutation such as BRCA1 or BRCA2 2. Population B - Inclusion criteria * Age ≥ 18 years * Newly diagnosed breast cancer with no previous history of breast cancer * Availability of pre-operative breast MRI performed for local staging within 4 weeks before the surgery * Breast surgery performed at the UniversitätsSpital Zürich 3. Population C - Inclusion criteria * Age ≥ 18 years * Newly detected BI-RADS 3 or 4 lesion * Availability of follow-up examination or histological results of biopsy and surgery 4. Population D - Inclusion criteria * Age ≥ 18 years * Availability of breast MRI performed for evaluating breast implants integrity Exclusion Criteria: 1\) Population A - Exclusion criteria: * Personal history of breast or ovarian cancer
References
Publications (0)
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