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

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Jul 24, 2023

Keywords

ClinConnect Summary

The COOL-IT-PRO trial is studying a treatment called cryoablation for patients with breast cancer who cannot have surgery. Cryoablation is a procedure that uses extreme cold to destroy cancer cells. This trial is specifically for individuals whose breast cancer cannot be treated with surgery due to various reasons, such as health issues that prevent them from undergoing anesthesia, cancer that has spread too much, or personal choice. To participate, you must be at least 18 years old, have a diagnosis of breast cancer, and have a tumor that can be seen on an ultrasound.

If you join this trial, you will receive cryoablation and be part of a registry, which means your health information will be collected over time to help researchers evaluate the safety and effectiveness of this treatment for patients in similar situations. The trial is currently recruiting participants of all genders, aged between 18 and 74. By taking part, you will contribute to important research that could benefit others with breast cancer in the future.

Gender

ALL

Eligibility 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.