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RecruitingObservational

COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients: A Prospective Observational Registry

NCT ID: NCT05972343Sponsor: Washington University School of MedicineLast updated: 2026-05-07

Summary

This is a subject registry study of patients who undergo cryoablation for their breast cancer after being determined not to be surgical candidates. Data collected as part of this registry will be used to assess the safety of percutaneous ultrasound-guided cryoablation in this population as well as provide long-term follow-up of subjects who received cryoablation.

Arms & interventions

  • DeviceCryoablation

    Takes place at single time point.

Outcome measures

Primary

  • Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0

    Time frame: Through 3 year follow-up

Secondary

  • Proportion of patients who demonstrate progression-free survival (PFS)

    Time frame: At 3 year follow-up

  • Proportion of patients who demonstrate disease-free survival (DFS)

    Time frame: At 3 year follow-up

  • Proportion of patients who demonstrate overall survival (OS)

    Time frame: At 3 year follow-up

Eligibility criteria

Sex: AllAge: 18 Years and olderHealthy volunteers: No
Eligibility Criteria: * Diagnosis of breast cancer. * Mass must be visible on ultrasound and \> 5 mm from skin. * Not undergoing surgery, because: * Patient has a medical condition that would not allow sedation or general anesthesia * Surgery is not clinically indicated due to unresectable and/or metastatic disease * Surgery is not clinically indicated for another reason * Patient declines surgery * At least 18 years old. * Able to understand and willing to sign an IRB-approved written informed consent document.

Study locations (1)

Washington University School of Medicine

St Louis, Missouri, 63110

Recruiting
Heather Garrett, M.D. · Contact
314-454-5206hvgarrett@wustl.edu
Heather Garrett, M.D. · Principal Investigator
Debbie Bennett, M.D. · Sub Investigator
Julie Margenthaler, M.D. · Sub Investigator
Katherine Clifton, M.D. · Sub Investigator
Mariya Kristeva, M.D. · Sub Investigator
Jingqin Luo, Ph.D. · Sub Investigator
Christina Doherty, M.D. · Sub Investigator
Tabassum Ahmad, M.D. · Sub Investigator
COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients | Cancerify