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Recruiting

NCT Number: NCT05972343

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

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.

Recruiting

Interested in participating?

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Cancer of the Breast Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location status: Recruiting

Location contact

Christina Doherty, M.D.

SUB_INVESTIGATOR

Debbie Bennett, M.D.

SUB_INVESTIGATOR

Heather Garrett, M.D.

CONTACT

[email protected]

314-454-5206

Heather Garrett, M.D.

PRINCIPAL_INVESTIGATOR

Jingqin Luo, Ph.D.

SUB_INVESTIGATOR

Julie Margenthaler, M.D.

SUB_INVESTIGATOR

Katherine Clifton, M.D.

SUB_INVESTIGATOR

Mariya Kristeva, M.D.

SUB_INVESTIGATOR

Tabassum Ahmad, M.D.

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Cryoablation

Device

Takes place at single time point.

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-up

Secondary outcomes

  1. Proportion of patients who demonstrate progression-free survival (PFS)

    Time frame: At 3 year follow-up

  2. Proportion of patients who demonstrate disease-free survival (DFS)

    Time frame: At 3 year follow-up

  3. Proportion of patients who demonstrate overall survival (OS)

    Time frame: At 3 year follow-up

Study contacts

Contact information is provided by the study sponsor or research team.

Heather Garrett, M.D.

CONTACT

[email protected]

314-454-5206

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients: A Prospective Observational Registry

Important dates

Study start
2023
Primary completion
2031
Study completion
2031
First posted
Aug 2, 2023
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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