NCT07421479

Patient-Derived Breast Cancer Organoids for Therapeutic Extracellular Vesicle Isolation (PDO-Mercurial01)

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 50 (estimated)
• Sponsor: Istituti Clinici Scientifici Maugeri SpA · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to establish organoid cultures, which are three-dimensional in vitro tumor models capable of supporting the long-term ex vivo growth of tumor cells derived from patients with breast carcinoma. These organoids will be used for the isolation of extracellular vesicles (EVs), which are naturally released by cells and have the ability to selectively recognize tumor tissue. Due to these properties, EVs represent promising vectors for the targeted delivery of diagnostic agents, with potential applications in fluorescence-guided surgery.

Detailed description

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.

Conditions

• Invasive Breast Cancer

Interventions

Type	Name	Description
PROCEDURE	Blood and tumor tissue collection	This prospective multicenter and observational study aims to recruit breast cancer patients who are candidates for surgery.After obtaining written and verbal informed consent, the following clinical and anamnestic data will be prospectively collected for each patient: age, comorbidities, type of breast lesion, lesion size assessed by imaging and post-operative histopathology, histological type, TNM disease stage, tumor grade, and biomolecular profile. In addition, follow-up data will be collected for each patient, including type of surgical procedure, type of treatment, and final histological report. Follow-up will extend for five years after surgery and will include information on any disease recurrence and subsequent treatments. rganoid cultures will be generated from surgical specimens to isolate extracellular vesicles (EVs) and evaluate their potential as delivery systems for indocyanine green in fluorescence-guided surgery.

Timeline

• Start date: 2025-01-01
• Primary completion: 2027-10-28
• Completion: 2027-10-28
• First posted: 2026-02-19
• Last updated: 2026-02-19

Locations

1 site across 1 country: Italy