Breast CancerBreast-POCETNCT06932133
A Trial on the Use of Point-of-care Ultrasound in the Assessment of Breast Symptoms
A study testing Point-of-care ultrasound in people with Breast Cancer, run by Region Skane at 1 site in Sweden.
Trial summary
The high cost of diagnostic equipment, limited expertise, and inadequate infrastructure are major barriers to early breast cancer diagnosis in low- and middle-income countries. Point-of-care ultrasound (POCUS) offers a relatively low-cost, portable solution that, when combined with artificial intelligence (AI)-driven… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Point-of-care ultrasound
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteSweden
- Study dates
- 7 Apr 2025to 12 Feb 2027
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women (≥18 years of age) referred to diagnostic imaging with a suspicion on malignancy
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.
About this study
Official title: Breast Point-of-Care Ultrasound Examination Trial
The high cost of diagnostic equipment, limited expertise, and inadequate infrastructure are major barriers to early breast cancer diagnosis in low- and middle-income countries. Point-of-care ultrasound (POCUS) offers a relatively low-cost, portable solution that, when combined with artificial intelligence (AI)-driven image analysis, has the potential to significantly expand access to breast assessment in these settings. The purpose of this study is to evaluate the performance of POCUS for women with focal breast symptoms and to assess the performance of AI to analyze POCUS images. The study will be divided in two parts: a prospective interventional study and a retrospective multicase multireader study.
Read the detailed description
In this trial we want to understand if the use of POCUS is non-inferior to Standard of Care (SoC) and if the combination of POCUS AI can reach non-inferior performance to that of breast radiologists. There is a need for breast diagnostic tools in underserved countries since late-stage diagnosis is a major cause of the high breast-cancer mortality in low-and middle-income countries. Showing that POCUS can be sufficient for an assessment of focal breast symptoms can provide evidence for a broader use. Also, enabling automated interpretation using AI can add to the value of this low-cost and accessible solution. The first part of the trial is a prospective open-label accuracy study with paired design. The intervention of POCUS as a targeted diagnostic method for women with focal breast complaints will be compared with SoC. We will also be able to compare POCUS with the individual components of SoC (mammography and standard ultrasound) and retrospectively with POCUS AI. The second part of the trial is a single-blinded retrospective paired mulitcase multireader study. In this part we can directly assess POCUS and POCUS AI without the influence of mammography and benchmark to a larger group of radiologists and in addition compare with standard ultrasound
- Conditions
- Breast Cancer
- Being tested
- Point-of-care ultrasound
- Keywords
- artificial intelligence, point-of-care ultrasound
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Point-of-care ultrasoundDiagnostic test
Point-of-care ultrasound will be performed on symptomatic breast patients. The images will be analysed by AI
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Diagnostic Test: Point-of-care ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The area under the receiver operating characteristic curve (AUC) for the intervention, compared to that of the comparator
- The AUC of POCUS compared to SoC
- The AUC of AI compared to average radiologists on POCUS
Measured: From the last enrolled participant to the end of one-year follow up
Secondary outcomes (1)
The performance of POCUS and POCUS AI
- The sensitivity, specificity, PPV, and NPV of POCUS compared to SoC (Part 1)
- The sensitivity, specificity, PPV, and NPV of POCUS compared to standard ultrasound (Part 1)
- The sensitivity, specificity, PPV, and NPV of POCUS compared to mammography (Part 1)
- The AUC of POCUS AI compared to SoC (Part 1)
- The AUC, sensitivity, and specificity of POCUS in relation to tumor type, stage, breast density, previous history of breast cancer, age, and demographics (Part 1 and Part 2)
- The AUC, sensitivity and specificity of POCUS AI in relation to tumor type, stage, breast density, previous history of breast cancer, age, and demographics (Part 1 and Part 2)
- The sensitivity, specificity, PPV, and NPV of average radiologists on POCUS compared to standard ultrasound (Part 2)
- The sensitivity and specificity of POCUS AI at different operating thresholds (Part 2)
- The balanced accuracy of POCUS AI compared to average radiologists (Part 2)
- The AUC, sensitivity, and specificity of POCUS AI
Measured: From the last enrolled participants to the end of one year follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2025
- Study start7 Apr 2025
- Primary completion12 Feb 2026
- Study completion12 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kristina Lång, MD PhD, Principal investigator, Lund University, Unilabs Mammography
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06932133
- Sponsor's protocol ID
- CIV-ID 24-10-049596
- Acronym
- Breast-POCET
- Status last verified
- Feb 2026
- First submitted
- 10 Apr 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: De-identified data will be made available upon reasonable request, with investigator support and a signed data access agreement. A proposal should be submitted to be reviewed by the study steering committee. Individual data are not publicly available due to data protection regulations. The Clinical Investigator Plan is available online at https://portal.research.lu.se/sv/projects/breast-point-of-care-examination-trial
Publications
Karlsson J, Arvidsson I, Sahlin F, Astrom K, Overgaard NC, Lang K, Heyden A. Breast cancer classification in point-of-care ultrasound imaging-the impact of training data. J Med Imaging (Bellingham). 2025 Jan;12(1):014502. doi: 10.1117/1.JMI.12.1.014502. Epub 2025 Jan 17.
PubMed 39830074Karlsson, J, Wodrich, M, Overgaard, NC, Sahlin, F, Lång, K, Heyden, A & Arvidsson, I 2025, Towards Out-of-Distribution Detection for Breast Cancer Classification in Point-of-Care Ultrasound Imaging. in, Pattern Recognition - 27th International Conference, ICPR 2024, Proceedings, Part XIII. Lecture Notes in Computer Science
Wodrich, M, Karlsson, J, Lång, K & Arvidsson, I 2025, Trustworthiness for Deep Learning Based Breast Cancer Detection Using Point-of-Care Ultrasound Imaging in Low-Resource Settings. in Medical Information Computing: MICCAI Meets Africa Workshop, https://doi.org/10.1007/978-3-031-79103-1_5.
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Point-of-Care Ultrasound Examination Trial
- ClinicalTrials.gov ID
- NCT06932133
- Acronym / sponsor ID
- Breast-POCET / CIV-ID 24-10-049596
- Conditions
- Breast Cancer
- Keywords
- artificial intelligence, point-of-care ultrasound
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 12 Feb 2026 (actual)
- Study completion
- 12 Feb 2027 (estimated)
- First posted
- 17 Apr 2025 (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.
The high cost of diagnostic equipment, limited expertise, and inadequate infrastructure are major barriers to early breast cancer diagnosis in low- and middle-income countries. Point-of-care ultrasound (POCUS) offers a relatively low-cost, portable solution that, when combined with artificial intelligence (AI)-driven image analysis, has the potential to significantly expand access to breast assessment in these settings. The purpose of this study is to evaluate the performance of POCUS for women with focal breast symptoms and to assess the performance of AI to analyze POCUS images. The study will be divided in two parts: a prospective interventional study and a retrospective multicase multireader study.
Detailed description
In this trial we want to understand if the use of POCUS is non-inferior to Standard of Care (SoC) and if the combination of POCUS AI can reach non-inferior performance to that of breast radiologists. There is a need for breast diagnostic tools in underserved countries since late-stage diagnosis is a major cause of the high breast-cancer mortality in low-and middle-income countries. Showing that POCUS can be sufficient for an assessment of focal breast symptoms can provide evidence for a broader use. Also, enabling automated interpretation using AI can add to the value of this low-cost and accessible solution. The first part of the trial is a prospective open-label accuracy study with paired design. The intervention of POCUS as a targeted diagnostic method for women with focal breast complaints will be compared with SoC. We will also be able to compare POCUS with the individual components of SoC (mammography and standard ultrasound) and retrospectively with POCUS AI. The second part of the trial is a single-blinded retrospective paired mulitcase multireader study. In this part we can directly assess POCUS and POCUS AI without the influence of mammography and benchmark to a larger group of radiologists and in addition compare with standard ultrasound
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: Point-of-care ultrasound |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Women (≥18 years of age) referred to diagnostic imaging with a suspicion on malignancy
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 |
|---|---|---|
| Point-of-care ultrasoundPoint-of-care ultrasound will be performed on symptomatic breast patients. The images will be analysed by AI | Diagnostic test | Intervention |
Primary outcome
The area under the receiver operating characteristic curve (AUC) for the intervention, compared to that of the comparator
Time frame: From the last enrolled participant to the end of one-year follow up
1. The AUC of POCUS compared to SoC 2. The AUC of AI compared to average radiologists on POCUS
1 secondary outcome
The performance of POCUS and POCUS AI
Time frame: From the last enrolled participants to the end of one year follow up
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 30 Mar 2026.
- Background: PubMed 39830074Karlsson J, Arvidsson I, Sahlin F, Astrom K, Overgaard NC, Lang K, Heyden A. Breast cancer classification in point-of-care ultrasound imaging-the impact of training data. J Med Imaging (Bellingham). 2025 Jan;12(1):014502. doi: 10.1117/1.JMI.12.1.014502. Epub 2025 Jan 17.
- BackgroundKarlsson, J, Wodrich, M, Overgaard, NC, Sahlin, F, Lång, K, Heyden, A & Arvidsson, I 2025, Towards Out-of-Distribution Detection for Breast Cancer Classification in Point-of-Care Ultrasound Imaging. in, Pattern Recognition - 27th International Conference, ICPR 2024, Proceedings, Part XIII. Lecture Notes in Computer Science
- BackgroundWodrich, M, Karlsson, J, Lång, K & Arvidsson, I 2025, Trustworthiness for Deep Learning Based Breast Cancer Detection Using Point-of-Care Ultrasound Imaging in Low-Resource Settings. in Medical Information Computing: MICCAI Meets Africa Workshop, https://doi.org/10.1007/978-3-031-79103-1_5.
- Official webpage of Lund University research portal and the webpage of the PILink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data will be made available upon reasonable request, with investigator support and a signed data access agreement. A proposal should be submitted to be reviewed by the study steering committee. Individual data are not publicly available due to data protection regulations. The Clinical Investigator Plan is available online at https://portal.research.lu.se/sv/projects/breast-point-of-care-examination-trial
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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 Lång, MD PhD principal investigator
Lund University, Unilabs Mammography
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Point-of-care ultrasound in people with Breast Cancer, run by Region Skane at 1 site in Sweden.
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 1 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 30 Mar 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 Sweden. 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?
The area under the receiver operating characteristic curve (AUC) for the intervention, compared to that of the comparator (time frame: From the last enrolled participant to the end of one-year follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06932133, which also lists 3 linked publications.
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 30 Mar 2026.