COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients
COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients: A Prospective Observational Registry
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Procedures mentioned: Ultrasound
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tracks people with breast cancer who have cryoablation, a treatment that freezes cancer, instead of surgery. It checks the safety of this treatment when guided by ultrasound through the skin and follows patients over time.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- Have breast cancer.
- The tumor can be seen on ultrasound and is more than 5 millimeters from the skin.
- Are not having surgery because a health problem prevents the use of drugs to relax you or put you to sleep; the cancer cannot be removed or has spread; surgery is not advised for another reason; or you choose not to have surgery.
- Are at least 18 years old.
- Can understand and are willing to sign a written form agreeing to join the study.
Who can't join
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility 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.
Study sites (1)
MO
- Washington University School of Medicine · St Louis, MO 63110Heather Garrett, M.D. · Study contact · 314-454-5206 · hvgarrett@wustl.eduHeather Garrett, M.D. · Principal investigatorDebbie Bennett, M.D. · Sub-investigatorJulie Margenthaler, M.D. · Sub-investigatorMore trials in St Louis