Clincosm LogoSign in Get a demo

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

Sponsor
Washington University School of Medicine (Other)
Overall Status
Recruiting
CT.gov ID
NCT05972343
Collaborator
(none)
100
Enrollment
1
Location
96.2
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Cryoablation

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
100 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients: A Prospective Observational Registry
Actual Study Start Date :
Jul 26, 2023
Anticipated Primary Completion Date :
Jul 31, 2031
Anticipated Study Completion Date :
Jul 31, 2031

Arms and Interventions

Arm Intervention/Treatment
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.

Device: Cryoablation
Takes place at single time point.

Outcome Measures

Primary Outcome Measures

  1. Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0 [Through 3 year follow-up]

Secondary Outcome Measures

  1. Proportion of patients who demonstrate progression-free survival (PFS) [At 3 year follow-up]

  2. Proportion of patients who demonstrate disease-free survival (DFS) [At 3 year follow-up]

  3. Proportion of patients who demonstrate overall survival (OS) [At 3 year follow-up]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

  • Principal Investigator: Heather Garrett, M.D., Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT05972343
Other Study ID Numbers:
  • 202307067
First Posted:
Aug 2, 2023
Last Update Posted:
Aug 3, 2023
Last Verified:
Aug 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Aug 3, 2023