System-integrated Point-of-Care Ultrasound in Breast Cancer Screening (SPRING)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: AI

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.

• Study Type: Interventional
• Enrollment (Estimated): 4800
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kristina KL Lång, MD PhD; Phone Number: +4640338880; Email: kristina.lang@med.lu.se
• Study Contact Backup: Name: Abayneh ATT Tunje Tanga, PhD; Email: abaynehtun@gmail.com

Study Locations

• Ethiopia
  • Gamo Zone
    • Arba Minch, Gamo Zone, Ethiopia
      • Recruiting
      • Arba Minch University and health care facilities and markets in the Gamo Zone
      • Contact: Abayneh T Tunje, PhD; Phone Number: +251920011972; Email: abaynehtun@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CBE follow by targeted AI-supported POCUS; In the first stage, an expert breast radiologist will be involved on site and in the second stage, remotely.	Diagnostic test: AI; AI-supported POCUS for triage

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Specificity	Proportion of non-diseased participants correctly classified as negative	2 months
Positive Predictive Value	Proportion of diseased participants of those referred for further workup	2 months
Negative Predictive Value	Proportion of true negatives among all negative results.	2 months
Cancer Detection Rate	Proportion of women with detected cancer among all screened women	2 months
Recall Rate	Proportion of women triaged to further work up	2 months
False Positive Rate	Proportion of participants triaged for work up with no detected cancer among all screened participants.	2 months
Optimal threshold analysis	Sensitivity and specificity at the point minimizing distance to (0,1) on the ROC curve.	2 months
Cancer characterstics	Distribution of cancer stage and histological type among detected cancers.	6 months
Breast cancer in stage I-II	Proportion of breast cancer in stage I-II compared to historical standard-of-care data (2021-2025).	12 months
WHO Global Breast Cancer Initiative key performance indicators	Proportion of participants with cancer in relation to the WHO Global Breast Cancer Initiative key performance indicators ( ≥60% of breast cancers diagnosed at stage I-II, ≤60 days from first presentation to diagnosis ≥80% completion of recommended treatment).	12 months
Receiver Operating Characteristic and Area Under the Curve	Based on the AI-generated probability score (0-1), using standard ROC analysis	2 months
Usability and Acceptability	Reported usability and acceptability of the AI-supported POCUS system: qualitative measure based on questionnaires (standard usability scale 1-5 and proportion of technical issues (y/n)).	2 months

Collaborators and Investigators

• Sponsor: Region Skane
• Collaborators: Arba Minch University
• Investigators: Principal Investigator: Kristina KL Lån g, MD PhD, Lund University

Study record dates

Study Major Dates

• Study Start (Actual): March 11, 2026
• Primary Completion (Estimated): May 23, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: March 5, 2026
• First Submitted That Met QC Criteria: March 5, 2026
• First Posted (Actual): March 10, 2026

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Ultrasound; Screening; Point-of-care ultrasound; Artificial intelligence; Low- and middle-income countries; Global health; clinical breast exam
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms
• Other Study ID Numbers: AT23460; 2025-03460 (Other Grant/Funding Number: The Swedish Research Council)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Due to data privacy. Could be considered following regulatory approvals.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No