Clinical trial · Interventional
System-integrated Point-of-Care Ultrasound in Breast Cancer Screening
NCT07462351CI-TRIAL-00124322SPRINGactive not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
To assess the feasibility, safety, and clinical performance of community-based breast cancer screening incorporating clinical breast exam and short-termed trained examiners performing AI-supported breast POCUS for triage in limited-resource settings.
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 |
|---|---|---|---|
| AI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- CBE follow by targeted AI-supported POCUS
- description
- In the first stage, an expert breast radiologist will be involved on site and in the second stage, remotely.
- interventionNames
- Diagnostic Test: AI
Primary outcomes (1)
- measure
- Sensitivity
- timeFrame
- Estimated 2 months (from enrollment until sufficient number of positive participants according to expert assessment)
- description
- The primary endpoint is sensitivity, defined as the proportion of diseased women correctly classified as positive by non-experts using AI-supported POCUS. Expert breast radiologists will be used as reference standard
Secondary outcomes (12)
- measure
- Specificity
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Asymptomatic women from the age of 30 with no upper age limit * Symptomatic women 18 years or older. Exclusion Criteria: * Individuals unable to comprehend the study information due to language barriers or cognitive impairments.
References
Publications (0)
Data not yet available
No reference posted for this study.