COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients
Purpose
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.
Conditions
- Breast Cancer
- Cancer of the Breast
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Prospective
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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. |
|
Recruiting Locations
Saint Louis, Missouri 63110
More Details
- NCT ID
- NCT05972343
- Status
- Recruiting
- Sponsor
- Washington University School of Medicine