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

Part of paid clinical trials in St Louis, Missouri.

Sponsor
Washington University School of Medicine
Study ID
NCT05972343
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Cryoablation — DEVICE
    Takes place at single time point.

Study Details

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.

Key Dates

Start date
Jul 26, 2023
Status verified
May 2026
Primary completion
Jul 31, 2031
Completion
Jul 31, 2031

Study Design

Enrollment
100 participants (estimated)

Arms

  • Arm: 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.

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

Locations (1)

FacilityCityStateZIPSite coordinators
Washington University School of MedicineSt LouisMissouri63110
Heather Garrett, M.D.
[email protected]
314-454-5206
Heather Garrett, M.D. (PRINCIPAL_INVESTIGATOR)
Debbie Bennett, M.D. (SUB_INVESTIGATOR)
Julie Margenthaler, M.D. (SUB_INVESTIGATOR)
Katherine Clifton, M.D. (SUB_INVESTIGATOR)
Mariya Kristeva, M.D. (SUB_INVESTIGATOR)
Jingqin Luo, Ph.D. (SUB_INVESTIGATOR)
Christina Doherty, M.D. (SUB_INVESTIGATOR)
Tabassum Ahmad, M.D. (SUB_INVESTIGATOR)

Find similar trials in St Louis, MO

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Washington University School of Medicine· St Louis, MO

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