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

Overseen By Heather Garrett, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Surgical candidates, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Heather Garrett, M.D.

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

Inclusion Criteria

You have been diagnosed with breast cancer.

The patient is medically unable to receive sedation or general anesthesia.

Surgery is not recommended because the disease cannot be removed and/or has spread.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

Pre-procedural Imaging Evaluation

Pre-procedural imaging evaluation to assess suitability for cryoablation

Cryoablation Treatment

Participants receive ultrasound-guided percutaneous cryoablation for breast cancer

Follow-up

Participants are monitored for safety and effectiveness after cryoablation with follow-up imaging at 6 months, 12 months, and annually until 3 years post-procedure

3 years

Treatment Details

Participant Groups

Group I: Cryoablation Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+