COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients

Washington University School of Medicine100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Breast Cancer Cancer of the Breast

Interventions

CryoablationDEVICE

Takes place at single time point.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Through 3 year follow-up

Secondary Outcomes

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

Central Contacts

Heather Garrett, M.D.

CONTACT

314-454-5206 hvgarrett@wustl.edu

Data from ClinicalTrials.gov

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