System-integrated Point-of-Care Ultrasound in Breast Cancer Screening
ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorRegion Skane
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Asymptomatic women from the age of 30 with no upper age limit
Symptomatic women 18 years or older.
Disqualifiers
Individuals unable to comprehend the study information due to language barriers or cognitive impairments.
Trial design
Design model
Single group
Treatments tested in this trial
AI
Diagnostic testAI-supported POCUS for triage
Treatment groups
4,800 Participants
are divided into 1 treatment groupGroup A: CBE follow by targeted AI-supported POCUSExperimental treatment 1 intervention
Trial outcomes
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
Time frame
Estimated 2 months (from enrollment until sufficient number of positive participants according to expert assessment)Secondary outcomes
1
Specificity
Proportion of non-diseased participants correctly classified as negative
Time frame
2 months2
Positive Predictive Value
Proportion of diseased participants of those referred for further workup
Time frame
2 months3
Negative Predictive Value
Proportion of true negatives among all negative results.
Time frame
2 months4
Cancer Detection Rate
Proportion of women with detected cancer among all screened women
Time frame
2 monthsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov