Prospective Single-center Study for the Generation of Organoids From Patients With Breast Carcinoma for Use in Extracellular Vesicle Isolation

Breast cancer is the leading cause of cancer-related mortality among European women. Despite advances in diagnosis and treatment, disease recurrence and therapy resistance remain major challenges. Improving the specific visualization of tumor tissue is essential to support precision medicine approaches and enable more accurate surgical resections.

Extracellular vesicles (EVs), naturally released by cells, have shown the ability to selectively recognize tumor tissue and represent promising vectors for targeted delivery of diagnostic agents. However, their clinical application is currently limited by the lack of reliable and representative sources. This project proposes the use of patient-derived organoids (PDOs) as a controlled and patient-specific source of EVs to better study their biological functions and diagnostic potential.

PDOs are accurate and personalized three-dimensional tumor models that recapitulate the biological and clinical characteristics of individual breast cancers. Differences between tumor-derived and healthy tissue samples will also be explored.

This prospective, single-center, observational study will recruit breast cancer patients undergoing surgery at IRCCS ICS Maugeri (Pavia). Clinical and pathological data will be collected prospectively, along with a 5-year follow-up to monitor disease recurrence and treatments. Organoids will be generated from surgical specimens to isolate EVs, which will be investigated as delivery systems for indocyanine green fluorescent contrast agents in FGS applications. No additional clinical procedures or blood samples beyond standard care are required.