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
• Status: Recruiting
• 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
• 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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cancer of the Breast

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

External Links

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