Cryoablation treatment for breast cancer in patients who can't have surgery
COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients: A Prospective Observational Registry
This study is testing whether a freezing treatment called cryoablation can safely help people with breast cancer who can't have surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Trial ID | NCT05972343 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with breast cancer who are not candidates for surgery. It involves the use of cryoablation, a minimally invasive procedure that destroys cancer cells by freezing them, guided by ultrasound. The study aims to collect data on the safety and long-term outcomes of cryoablation in this specific patient population. Participants will be monitored over time to assess the effectiveness and safety of the treatment.
Who should consider this trial
Good fit: Ideal candidates include adults diagnosed with breast cancer who are not surgical candidates due to medical conditions or personal choices.
Not a fit: Patients with breast cancer who are eligible for surgical intervention may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a viable treatment option for patients with breast cancer who cannot undergo surgery.
How similar studies have performed: While this approach is relatively novel, similar studies on cryoablation for other cancers have shown promising results.
Eligibility criteria
Show full inclusion / 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.
Where this trial is running
St Louis, Missouri
- Washington University School of Medicine — St Louis, Missouri, United States (Recruiting)
Study contacts
- Principal investigator: Heather Garrett, M.D. — Washington University School of Medicine
- Study coordinator: Heather Garrett, M.D.
- Email: hvgarrett@wustl.edu
- Phone: 314-454-5206
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.