The IntelliBra clinical study
IntelliBra is being evaluated across Cameroon to learn how portable, AI-assisted screening can help frontline clinicians detect breast cancer earlier. The study will welcome 2,840 women aged 25 and above, with every examination provided free of charge.
A rigorous multicenter evaluation of AI-powered breast cancer screening across all 10 regions of Cameroon
IntelliBra is a connected brassiere integrating miniaturized ultrasound sensors and infrared thermography, analyzed by an embedded AI algorithm in real time. It connects to a mobile application that transmits results to the Cameroon National Breast Cancer Registry (CNBCR).
Results are compared against the standard reference examination: breast ultrasound for women under 40 and digital mammography for women aged 40 and above. In cases of suspected abnormality, biopsy serves as the definitive reference standard.
The primary aim is to measure the sensitivity and specificity of IntelliBra versus the reference standard. Secondary outcomes include PPV, NPV, AUC, patient acceptability, ease of use, and early detection rate.
All participant data is anonymized and stored in the CNBCR. No national identity number is collected. Data is accessible only to authorized researchers and shared upon formal request with ethical approval.
A phased approach to rigorous clinical validation
Phase 0
Formation of research team, ethics submission to CNERSH, regulatory filing with Cameroon health authorities, equipment deployment across 20 sites, staff training. Self-financed by ANORA S.A.S.
Phase I
10 participants
Initial testing of study procedures and protocols before full-scale deployment. Feasibility and protocol validation. Results used to confirm readiness for expansion.
Phase II
50 participants
Validation of Phase I results on a broader sample. Comparative analysis between phases. Funding secured through fundraising based on Phase I outcomes.
Phase III
2,840 participants
Complete multicenter study across all 10 regions. Final statistical analysis including sensitivity, specificity, AUC, PPV, NPV, and acceptability metrics. Submission for peer-reviewed publication.
+12 months
Summary results published in the PACTR registry and submitted to peer-reviewed journals per WHO requirements. Data made available via the CNBCR platform for qualified secondary research.
Eligibility at a glance
Screening is free. Participation is voluntary, and you can leave the study at any time.
A study clinician will confirm final eligibility and answer your questions.
Choose a region to see its participating hospitals.
Led by clinicians and researchers with deep expertise in cancer care and AI-powered diagnostics
Permanent Secretary, National Cancer Control Programme, Cameroon
UICC Technical Fellow 2024
Partners & sponsors
Reach the research team, ethics committee, or submit a data access request