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

The Washington University

Status: Enrolling

Conditions: Breast Cancer; Cancer of the Breast

Treatments: Device: Cryoablation

Study type: Observational

Funder types: Other

Identifiers

NCT05972343

202307067

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

100 participants in 1 patient group

Cryoablation

Description:

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.

Treatment:

Device: Cryoablation