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.

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.