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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-07-26

Study Completion Date

2031-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer Cancer of the Breast

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cryoablation

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.

Cryoablation

Intervention Type DEVICE

Takes place at single time point.

Interventions

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Cryoablation

Takes place at single time point.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No