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

Recruiting

• Conditions: Breast Cancer; Cancer of the Breast
• Interventions: Device: Cryoablation

• Registration Number: NCT05972343
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-07-24
• Study First Submitted QC: 2023-07-24
• Study Start: 2023-07-26
• Study First Posted: 2023-08-02
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-03
• Last Update Posted: 2025-05-06
• Primary Completion: 2031-07-31
• Study Completion: 2031-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cryoablation	Cryoablation	Following pre-procedural imaging evaluation, patients will receive ultrasound-guided percutaneous cryoablation as part of their routine treatment of their breast cancer. Follow up imaging (if tolerated) will be performed at 6 months and 12 months and annually thereafter for until 3 years post-procedure. Data will be collected on patient demographics, disease characteristics, treatment, treatment complications, follow-up imaging, response (for 3 years post-procedure), and quality of life.

Primary Outcome Measures

Name	Time	Method
Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0	Through 3 year follow-up

Secondary Outcome Measures

Name	Time	Method
Proportion of patients who demonstrate progression-free survival (PFS)	At 3 year follow-up
Proportion of patients who demonstrate disease-free survival (DFS)	At 3 year follow-up
Proportion of patients who demonstrate overall survival (OS)	At 3 year follow-up

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States