Breast CancerSPRINGNCT07462351
System-integrated Point-of-Care Ultrasound in Breast Cancer Screening
A study testing AI in people with Breast Cancer, run by Region Skane at 1 site in Ethiopia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- AI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,800 participants
- Where
- 1 siteEthiopia
- Study dates
- 11 Mar 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Asymptomatic women from the age of 30 with no upper age limit
- Symptomatic women 18 years or older.
Who cannot join
- Individuals unable to comprehend the study information due to language barriers or cognitive impairments.
Trial locations and contacts
1 site in 1 country.
Ethiopia1 site
Arba Minch University and health care facilities and markets in the Gamo Zone
Arba Minch, Gamo Zone
About this study
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- AI
- Keywords
- Screening, Low- and middle-income countries, Global health, Artificial intelligence, Ultrasound, Point-of-care ultrasound, clinical breast exam
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AIDiagnostic test
AI-supported POCUS for triage
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: AI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Estimated 2 months (from enrollment until sufficient number of positive participants according to expert assessment)
Secondary outcomes (12)
Specificity
Proportion of non-diseased participants correctly classified as negative
Measured: 2 months
Positive Predictive Value
Proportion of diseased participants of those referred for further workup
Measured: 2 months
Negative Predictive Value
Proportion of true negatives among all negative results.
Measured: 2 months
Cancer Detection Rate
Proportion of women with detected cancer among all screened women
Measured: 2 months
Recall Rate
Proportion of women triaged to further work up
Measured: 2 months
False Positive Rate
Proportion of participants triaged for work up with no detected cancer among all screened participants.
Measured: 2 months
Receiver Operating Characteristic and Area Under the Curve
Based on the AI-generated probability score (0-1), using standard ROC analysis
Measured: 2 months
Optimal threshold analysis
Sensitivity and specificity at the point minimizing distance to (0,1) on the ROC curve.
Measured: 2 months
Cancer characterstics
Distribution of cancer stage and histological type among detected cancers.
Measured: 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).
Measured: 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).
Measured: 12 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)).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start11 Mar 2026
- Primary completion31 Jul 2026
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Region SkaneThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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%.
- Masking
- None (open label)
- Enrolment
- 4,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Collaborators
- Arba Minch University
- Responsible party
- Principal investigator, Kristina Lång, Lund University
- Investigators
- Kristina KL Lån g, MD PhD, Principal investigator, Lund University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07462351
- Sponsor's protocol ID
- AT23460
- Other IDs
- 2025-03460, 2025
- Acronym
- SPRING
- Status last verified
- Aug 2026
- First submitted
- 5 Mar 2026
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to data privacy. Could be considered following regulatory approvals.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- System-integrated Point-of-Care Ultrasound in Breast Cancer Screening
- ClinicalTrials.gov ID
- NCT07462351
- Acronym / sponsor ID
- SPRING / AT23460
- Conditions
- Breast Cancer
- Keywords
- Screening, Low- and middle-income countries, Global health, Artificial intelligence, Ultrasound, Point-of-care ultrasound, clinical breast exam
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,800 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Collaborators
- Arba Minch University
- Study start
- 11 Mar 2026 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 10 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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%.
| Arm | Type | Receives |
|---|---|---|
| CBE follow by targeted AI-supported POCUS | Experimental | Diagnostic Test: AIIn the first stage, an expert breast radiologist will be involved on site and in the second stage, remotely. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Asymptomatic women from the age of 30 with no upper age limit
- Symptomatic women 18 years or older.
Key exclusion criteria (1 listed)
- Individuals unable to comprehend the study information due to language barriers or cognitive impairments.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AIAI-supported POCUS for triage | Diagnostic test | CBE follow by targeted AI-supported POCUS |
Primary outcome
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
12 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Individual participant dataSharing planned: No. Due to data privacy. Could be considered following regulatory approvals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristina KL Lån g, MD PhD principal investigator
Lund University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AI in people with Breast Cancer, run by Region Skane at 1 site in Ethiopia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ethiopia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sensitivity (time frame: Estimated 2 months (from enrollment until sufficient number of positive participants according to expert assessment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.