Clinical trial · Observational
COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients
COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients: A Prospective Observational Registry
NCT05972343CI-TRIAL-00110735recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cancer of the Breast | Malignant Breast Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryoablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cryoablation
- description
- 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.
- interventionNames
- Device: Cryoablation
Primary outcomes (1)
- measure
- Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0
- timeFrame
- Through 3 year follow-up
Secondary outcomes (3)
- measure
- Proportion of patients who demonstrate progression-free survival (PFS)
- timeFrame
- At 3 year follow-up
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.