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NCT05972343 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05972343
Other study ID # 202307067
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 26, 2023
Est. completion date July 31, 2031

Study information
Verified date February 2024
Source Washington University School of Medicine
Contact Heather Garrett, M.D.
Phone 314-454-5206
Email hvgarrett@wustl.edu
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 100
Est. completion date July 31, 2031
Est. primary completion date July 31, 2031
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Device:
• Cryoablation
Takes place at single time point.

Locations
Country Name City State
United States Washington University School of Medicine Saint Louis Missouri

Sponsors (1)
Lead Sponsor Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0 Through 3 year follow-up
Secondary Proportion of patients who demonstrate progression-free survival (PFS) At 3 year follow-up
Secondary Proportion of patients who demonstrate disease-free survival (DFS) At 3 year follow-up
Secondary Proportion of patients who demonstrate overall survival (OS) At 3 year follow-up
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