Cryoablation treatment for breast cancer in patients who can't have surgery
Official title: COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients: A Prospective Observational Registry
Run by Washington University School of Medicine · NCT05972343 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 100 (estimated) |
| Sponsor | Washington University School of Medicine Academic / other |
| Locations | 1 site (St Louis, Missouri) |
| Status | Recruiting |
| Started | July 26, 2023 |
| Main results expected | July 31, 2031 |
| Study ends | July 31, 2031 |
| Registry record updated | May 7, 2026 |
| Trial ID | NCT05972343 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adults diagnosed with breast cancer who are not surgical candidates due to medical conditions or personal choices.
✕Probably not a fit
Patients with breast cancer who are eligible for surgical intervention may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While this approach is relatively novel, similar studies on cryoablation for other cancers have shown promising results.
Who can join: the full rules
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 it's running
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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
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.