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

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

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 Overview

• Status: Recruiting
• Conditions: Breast Cancer; Cancer of the Breast
• Intervention / Treatment: Device: Cryoablation

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Heather Garrett, M.D.; Phone Number: 314-454-5206; Email: hvgarrett@wustl.edu

Study Locations

• United States
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Recruiting
      • Washington University School of Medicine
      • Principal Investigator: Heather Garrett, M.D.
      • Sub-Investigator: Debbie Bennett, M.D.
      • Sub-Investigator: Christina Doherty, M.D.
      • Sub-Investigator: Tabassum Ahmad, M.D.
      • Sub-Investigator: Jingqin Luo, Ph.D.
      • Sub-Investigator: Katherine Clifton, M.D.
      • Sub-Investigator: Julie Margenthaler, M.D.
      • Contact: Heather Garrett, M.D.; Phone Number: 314-454-5206; Email: hvgarrett@wustl.edu
      • Sub-Investigator: Mariya Kristeva, M.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients seen at Siteman Cancer Center.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

Device: Cryoablation; Takes place at single time point.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Heather Garrett, M.D., Washington University School of Medicine

Publications and helpful links

Helpful Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2023
• Primary Completion (Estimated): July 31, 2031
• Study Completion (Estimated): July 31, 2031

Study Registration Dates

• First Submitted: July 24, 2023
• First Submitted That Met QC Criteria: July 24, 2023
• First Posted (Actual): August 2, 2023

Study Record Updates

• Last Update Posted (Actual): May 7, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Surgical Procedures, Operative; Ablation Techniques; Cryosurgery
• Other Study ID Numbers: 202307067

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: In addition to the analyses proposed in this protocol, the data collected under this registry will be stored for potential (currently unknown) research projects and may be used to query for feasibility of future projects and other quality initiatives.
• IPD Sharing Access Criteria: Requests from individuals outside Washington University will require a formal data use agreement (DUA) before release of data for limited data sets and/or identifiable data sets.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No