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NCT Number: NCT07462351

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

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Arba Minch, Gamo Zone, Ethiopia

Location status: Recruiting

Location contact

Abayneh T Tunje, PhD

CONTACT

[email protected]

+251920011972

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

AI

Diagnostic Test

AI-supported POCUS for triage

Primary outcomes

  1. Sensitivity

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

    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

  1. Specificity

    Time frame: 2 months

    Proportion of non-diseased participants correctly classified as negative

  2. Positive Predictive Value

    Time frame: 2 months

    Proportion of diseased participants of those referred for further workup

  3. Negative Predictive Value

    Time frame: 2 months

    Proportion of true negatives among all negative results.

  4. Cancer Detection Rate

    Time frame: 2 months

    Proportion of women with detected cancer among all screened women

  5. Recall Rate

    Time frame: 2 months

    Proportion of women triaged to further work up

  6. False Positive Rate

    Time frame: 2 months

    Proportion of participants triaged for work up with no detected cancer among all screened participants.

  7. Receiver Operating Characteristic and Area Under the Curve

    Time frame: 2 months

    Based on the AI-generated probability score (0-1), using standard ROC analysis

  8. Optimal threshold analysis

    Time frame: 2 months

    Sensitivity and specificity at the point minimizing distance to (0,1) on the ROC curve.

  9. Cancer characterstics

    Time frame: 6 months

    Distribution of cancer stage and histological type among detected cancers.

  10. Breast cancer in stage I-II

    Time frame: 12 months

    Proportion of breast cancer in stage I-II compared to historical standard-of-care data (2021-2025).

  11. WHO Global Breast Cancer Initiative key performance indicators

    Time frame: 12 months

    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. Usability and Acceptability

    Time frame: 2 months

    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)).

Study contacts

Contact information is provided by the study sponsor or research team.

Abayneh ATT Tunje Tanga, PhD

CONTACT

[email protected]

Kristina KL Lång, MD PhD

CONTACT

[email protected]

+4640338880

Sponsors and collaborators

Lead sponsor

Region Skane

Other

Collaborators

  • Arba Minch University

Registry information

Acronym: SPRING

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Mar 10, 2026
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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