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

February 12, 2026 updated by: Fabio Corsi, Istituti Clinici Scientifici Maugeri SpA

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • Istituti Clinici Scientifici Maugeri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients consecutively referred to the Breast Unit of the IRCCS ICS Maugeri in Pavia who have breast neoplasm will be included in the study.

Description

Inclusion Criteria:

  • Female subjects;
  • Confirmed diagnosis of breast heteroplasia
  • Age >= 18 years;
  • Patients willing to follow the usual oncological follow-up;
  • Patients with de novo metastatic disease (M+), receiving primary chemotherapy, if candidates for primary tumor biopsy;
  • Subjects who agree to participate in the study by signing and dating the Informed Consent form.

Exclusion Criteria:

  • Patients without a proven cyto-histological diagnosis of breast carcinoma;
  • Subjects affected by other solid tumors besides the breast lesion.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Establishment of Patient-Derived Organoids of Breast Cancer
Time Frame: 36 months
Number and proportion of patients from which Patient-Derived Organoids lines will be succesfully established from collected tumor tissue samples
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istituti Clinici Scientifici Maugeri SpA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

October 28, 2027

Study Completion (Estimated)

October 28, 2027

Study Registration Dates

First Submitted

February 12, 2026

First Submitted That Met QC Criteria

February 12, 2026

First Posted (Actual)

February 19, 2026

Study Record Updates

Last Update Posted (Actual)

February 19, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

January 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDO-Mercurial 01 - CTSPV66-25

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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