Breast CancerNCT05972343
COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients
An observational study of Breast Cancer and Cancer of the Breast, run by Washington University School of Medicine at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Cancer of the Breast
- What is being tested?
- Cryoablation
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jul 2023to 31 Jul 2031
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seen at Siteman Cancer Center.
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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Washington University School of Medicine
St Louis, Missouri, 63110
Heather Garrett, M.D., 314-454-5206, hvgarrett@wustl.edu
Heather Garrett, M.D.
About this study
Official title: COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients: A Prospective Observational Registry
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.
- Conditions
- Breast Cancer, Cancer of the Breast
- Being tested
- Cryoablation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationDevice
Takes place at single time point.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0
Measured: Through 3 year follow-up
Secondary outcomes (3)
Proportion of patients who demonstrate progression-free survival (PFS)
Measured: At 3 year follow-up
Proportion of patients who demonstrate disease-free survival (DFS)
Measured: At 3 year follow-up
Proportion of patients who demonstrate overall survival (OS)
Measured: At 3 year follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2023
- Study start26 Jul 2023
- Primary completion31 Jul 2031 (estimated)
- Study completion31 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather Garrett, M.D., Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05972343
- Sponsor's protocol ID
- 202307067
- Status last verified
- May 2026
- First submitted
- 24 Jul 2023
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: In addition to the analyses proposed in this protocol, the data collected under this registry will be stored for potential (currently unknown) research projects and may be used to query for feasibility of future projects and other quality initiatives.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COOL-IT-PRO: Cryoablation of Breast Cancer in Non-surgical Patients: A Prospective Observational Registry
- ClinicalTrials.gov ID
- NCT05972343
- Acronym / sponsor ID
- 202307067
- Conditions
- Breast Cancer, Cancer of the Breast
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 26 Jul 2023 (actual)
- Primary completion
- 31 Jul 2031 (estimated)
- Study completion
- 31 Jul 2031 (estimated)
- First posted
- 2 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | – | Device: CryoablationFollowing 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seen at Siteman Cancer Center.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoablationTakes place at single time point. | Device | Cryoablation |
Primary outcome
Proportion of patients who are free of serious treatment related complications per CTCAE v 5.0
Time frame: Through 3 year follow-up
3 secondary outcomes
Proportion of patients who demonstrate progression-free survival (PFS)
Time frame: At 3 year follow-up
Proportion of patients who demonstrate disease-free survival (DFS)
Time frame: At 3 year follow-up
Proportion of patients who demonstrate overall survival (OS)
Time frame: At 3 year follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. In addition to the analyses proposed in this protocol, the data collected under this registry will be stored for potential (currently unknown) research projects and may be used to query for feasibility of future projects and other quality initiatives.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heather Garrett, M.D. principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Cancer of the Breast, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heather Garrett, M.D. (314-454-5206, hvgarrett@wustl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.