To hear about similar clinical trials, please enter your email below
Trial Title:
COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients
NCT ID:
NCT05972343
Condition:
Breast Cancer
Cancer of the Breast
Conditions: Official terms:
Breast Neoplasms
Study type:
Observational [Patient Registry]
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Device
Intervention name:
Cryoablation
Description:
Takes place at single time point.
Arm group label:
Cryoablation
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.
Criteria for eligibility:
Study pop:
Patients seen at Siteman Cancer Center.
Sampling method:
Non-Probability Sample
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.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Washington University School of Medicine
Address:
City:
Saint Louis
Zip:
63110
Country:
United States
Status:
Recruiting
Contact:
Last name:
Heather Garrett, M.D.
Phone:
314-454-5206
Email:
hvgarrett@wustl.edu
Investigator:
Last name:
Heather Garrett, M.D.
Email:
Principal Investigator
Investigator:
Last name:
Debbie Bennett, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Julie Margenthaler, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Katherine Clifton, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Mariya Kristeva, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Jingqin Luo, Ph.D.
Email:
Sub-Investigator
Investigator:
Last name:
Christina Doherty, M.D.
Email:
Sub-Investigator
Investigator:
Last name:
Tabassum Ahmad, M.D.
Email:
Sub-Investigator
Start date:
July 26, 2023
Completion date:
July 31, 2031
Lead sponsor:
Agency:
Washington University School of Medicine
Agency class:
Other
Source:
Washington University School of Medicine
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05972343
http://www.siteman.wustl.edu
