Recruiting

Cryoablation

Sponsor:

Washington University School of Medicine

Code:

NCT05972343

Conditions

Breast Cancer

Cancer of the Breast

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cryoablation

Study Details

Brief summary:

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

Breast Cancer

Cancer of the Breast

Study ID

NCT05972343

Start date

Jul 26, 2023

Status verified date

May, 2026

Completion date

Jul 31, 2031

Anticipated

Primary completion date

Jul 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Cryoablation

Takes place at single time point.

Primary outcome measure

  • Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0 [ Time Frame: Through 3 year follow-up ]

Central Contacts and Locations

Central contacts

Heather Garrett, M.D.

314-454-5206hvgarrett@wustl.edu

Locations

Washington University School of Medicine

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Heather Garrett, M.D.

314-454-5206hvgarrett@wustl.edu

Principal Investigator:

Heather Garrett, M.D.

More Information

Sponsor

Washington University School of Medicine

Last update posted

May 7, 2026

Last verified

May, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Washington University School of Medicine on 2026-05-07.