COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorWashington University School of Medicine
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosis of breast cancer.
Mass must be visible on ultrasound and > 5 mm from skin.
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
Disqualifiers
None
Trial population
Patients seen at Siteman Cancer Center.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Cryoablation
DeviceTakes place at single time point.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Cryoablation1 intervention
Trial outcomes
Primary outcomes
1
Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0
Time frame
Through 3 year follow-upSecondary outcomes
1
Proportion of patients who demonstrate progression-free survival (PFS)
Time frame
At 3 year follow-up2
Proportion of patients who demonstrate disease-free survival (DFS)
Time frame
At 3 year follow-up3
Proportion of patients who demonstrate overall survival (OS)
Time frame
At 3 year follow-upSponsors and contacts
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Source ClinicalTrials.gov