System-integrated Point-of-Care Ultrasound in Breast Cancer Screening

NCT07462351 | Recruiting

• 2 other identifiers: AT234602025-03460
• Study Type: interventional
• Target: 4,800
• Locations: 1 country
• Sites: 1

Brief Summary

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

Breast Cancer

Keywords

Screening; Low- and middle-income countries; Global health; Artificial intelligence; Ultrasound; Point-of-care ultrasound; clinical breast exam

Outcome Measures

Primary Outcomes (1)

• Sensitivity

  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

  Estimated 2 months (from enrollment until sufficient number of positive participants according to expert assessment)

Secondary Outcomes (12)

• Specificity

  2 months

• Positive Predictive Value

  2 months

• Negative Predictive Value

  2 months

• Cancer Detection Rate

  2 months

• Recall Rate

  2 months

Study Arms (1)

CBE follow by targeted AI-supported POCUS

EXPERIMENTAL

In the first stage, an expert breast radiologist will be involved on site and in the second stage, remotely.

Diagnostic Test: AI

Interventions

AI DIAGNOSTIC_TEST

AI-supported POCUS for triage

CBE follow by targeted AI-supported POCUS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Asymptomatic women from the age of 30 with no upper age limit
• Symptomatic women 18 years or older.

You may not qualify if:

• Individuals unable to comprehend the study information due to language barriers or cognitive impairments.

Sponsors & Collaborators

• Region Skane: lead
• Arba Minch University: collaborator

Study Sites (1)

Arba Minch University and health care facilities and markets in the Gamo Zone

Arba Minch, Gamo Zone, Ethiopia

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Kristina KL Lån g, MD PhD

  Lund University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina KL Lång, MD PhD

CONTACT

+4640338880; kristina.lang@med.lu.se

Abayneh ATT Tunje Tanga, PhD

CONTACT

abaynehtun@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: The result of AI-supported POCUS performed by nurse/clinical officer will be masked for the expert radiologist in the first stage of the study
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Model Details: The study will follow Simon's optimal two-stage phase II design (Simon, 1989) with type I error α = 0.05 and power 80% (β = 0.20). The primary endpoint is sensitivity, defined as the proportion of diseased participants correctly classified as positive by non-experts using AI-supported POCUS, with expert breast radiologists as the reference standard. Null hypothesis (H₀): Sensitivity ≤ 0.80, alternative hypothesis (H₁): Sensitivity ≥ 0.90. A sensitivity of 80% is considered the minimum acceptable level for clinical utility, while 90% represents the target performance based on prior pilot data and expert consensus. In stage 1, enrollment continues until 28 diseased cases are confirmed; if ≤23 are correctly classified, the study stops for futility. Otherwise, enrollment proceeds to 97 diseased cases. The null hypothesis will be rejected if ≥83 cases are correctly classified. This design yields a significance level of 0.0475 and power of 80.2%.

Study Record Dates

• First Submitted: March 5, 2026
• First Posted: March 10, 2026
• Study Start: March 11, 2026
• Primary Completion: May 23, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ET (1)