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Percutaneous Cryoablation of Low-risk Early Breast Cancer

NCT06300125 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 234

Last updated 2026-01-06

No results posted yet for this study

Summary

Expand the current evidence base regarding percutaneous cryoablation of early-stage, low-risk breast tumors, integrated into the standard therapeutic pathway with well-defined follow-up data, as well as data on quality of life. Demonstrate, therefore, that the use of percutaneous cryoablation in the treatment of low-risk breast carcinoma is not inferior to surgery when combined with adjuvant radiotherapy and chemotherapy (when necessary). The hypothesis is that cryoablation, being simple and oncologically effective, ensures a better quality of life for the patient (reduced morbidity, no need for general anesthesia, improved cosmetic outcomes) and consequently has a lesser psychological impact, as well as a better cost-benefit ratio compared to the standard surgical approach.

Conditions

Interventions

PROCEDURE

Cryoablation

Percutaneous Cryoablation of Breast Cancer

Sponsors & Collaborators

  • Fondazione Umberto Veronesi

    collaborator OTHER

  • IceCure Medical Ltd.

    collaborator INDUSTRY

  • European Institute of Oncology

    lead OTHER

Principal Investigators

  • Franco Orsi, MD · European Institute of Oncology

Eligibility

Min Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-15
Primary Completion
2026-12-31
Completion
2031-03-01

Countries

  • Italy

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06300125 on ClinicalTrials.gov