System-integrated Point-of-Care Ultrasound in Breast Cancer Screening
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: AI.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ethiopia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Detailed description
Following awareness campaign, asymptomatic and symptomatic women are invited to breast cancer screening. The screening intervention consists initially of clinical breast exam (CBE). Those that are positive at CBE or that present with symptoms are further examined with targeted artificial intelligence (AI)-supported breast point-of-care ultrasound (POCUS) on the complaint site. The AI-supported POCUS is performed by clinical nurses or clinical officers that have undergone a short training program and certification process in POCUS examination. In the first stage of the study, the same women will also be examined by an expert on site (breast radiologist). If clinical safety can be determined, the second stage of the study will start in which expert radiologist will not be on site. Ultrasound images will be assessed by breast radiologists that will serve as reference standard (on site in stage 1 and remotely in stage 2). Women positive at POCUS triage (positive ultrasound finding or with predefined alarming clinical symptoms) will be referred to further follow up.
Interventions
- Diagnostic test AI
AI-supported POCUS for triage
Primary outcome measures
- Sensitivity [Time frame: Estimated 2 months (from enrollment until sufficient number of positive participants according to expert assessment)]
Secondary outcome measures (12)
- Specificity [Time frame: 2 months]
- Positive Predictive Value [Time frame: 2 months]
- Negative Predictive Value [Time frame: 2 months]
- Cancer Detection Rate [Time frame: 2 months]
- Recall Rate [Time frame: 2 months]
- False Positive Rate [Time frame: 2 months]
- Receiver Operating Characteristic and Area Under the Curve [Time frame: 2 months]
- Optimal threshold analysis [Time frame: 2 months]
- Cancer characterstics [Time frame: 6 months]
- Breast cancer in stage I-II [Time frame: 12 months]
- WHO Global Breast Cancer Initiative key performance indicators [Time frame: 12 months]
- Usability and Acceptability [Time frame: 2 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Screening
Study locations
Ethiopia · 1 center
- Arba Minch University and health care facilities and markets in the Gamo Zone — Arba Minch
Identifiers
NCT: NCT07462351 · AT23460 · 2025-03460