Stereotactic Guided Biopsy and Cryoablation

February 24, 2026 updated by: Montefiore Medical Center

Stereotactic Guided Biopsy and Cryoablation of Breast Cancer

The purpose of this study is to evaluate a new strategy to treat small breast cancer called cryoablation, or cryosurgery, in combination with biopsy methods which are guided by certain imaging like mammography.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

For participants who choose to enroll in this study, the doctor will perform an excisional biopsy to remove the tumor (a biopsy to attempt to remove the whole tumor), after which a clip will be placed. Using the clip as a guide, the doctor will then cryoablate the biopsy cavity. Cryoablation is a kind of treatment that uses a hollow, thin tube, called a cryoprobe, to kill any residual tumor by freezing it. By conducting this study, the research team will investigate whether biopsy followed by cryoablation guided by mammography will prove to be an effective and safe way of treating breast cancers. It is anticipated that participation in this research will last about 2 years.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age 60 years or older, European Cooperative Oncology Group (ECOG) score 0-2
  • Lesion size 1.0 cm or smaller in greatest diameter. The largest diameter will be determined at the time of the diagnostic work up. For targets that are imaged in multiple modalities the largest diameter will prevail in determining eligibility. Note- 1.0 cm target size is chosen since extent may be underestimated upon initial diagnosis.
  • Biopsy proven DCIS, (including any lesion with DCIS +/- IDC)
  • Closest margin of target to the skin >15 mm
  • Compressed breast thickness to > 55mm
  • Unifocal primary disease (Patients with contralateral disease will remain eligible.)
  • Able to provide consent

Exclusion Criteria:

  • Multifocal or multicentric disease within the breast.
  • Prior surgical biopsy for diagnosis or treatment of index lesion.
  • Patients not suitable for stereotactic biopsy/cryoablation technique according to treating physician.
  • Patients receiving neoadjuvant therapy.
  • History of previously treated ipsilateral or contralateral breast carcinoma is not an exclusion criterion if the investigator is certain newly diagnosed carcinoma is a new unifocal primary tumor.
  • High-risk pathology (e.g., Grade 3, HER2+ status, Genomic high-risk score (if available)).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cryoablation
Device: Stereotactic Guided Biopsy and Cryoablation
Treatment of the lesion through a three-step procedure: 1) Tomosynthesis-guided stereotactic biopsy of the target (minimum 12 cores) which would include the initial tissue marking clip placed at time of initial diagnostic biopsy, then biopsy of the surrounding tissue using the same fixed sheath (minimum 12 cores) to allow for a better pathologic evaluation of extent of the target Ductal Carcinoma In Situ (DCIS). 2) Immediate cryoablation of biopsy site/cavity performed through the same sheath. 3) four post cryoablation biopsies through the same sheath to evaluate for any residual disease.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Overall feasibility
Time Frame: Up to 5 Years
Overall feasibility will be defined as study procedure completeness in more than 90% of enrolled patients AND data completeness in more than 90% of enrolled patients.
Up to 5 Years
Feasibility - Procedure Completeness
Time Frame: Within 1 month post procedure (+/- 7 days)
Study procedure completeness feasibility will be defined as the patient's ability to tolerate the entire single procedure consisting of stereotactic biopsy of central target & surrounding tissue + cryoablation of biopsy site/cavity + stereotactic biopsy (through the same sheath) of the post-cryoablation cavity. Study procedure completeness feasibility will be considered to have been met if > 90% of enrolled patients complete the procedure.
Within 1 month post procedure (+/- 7 days)
Feasibility - Data Completeness
Time Frame: Up to 5 Years
Data completeness feasibility will be defined as the ability to complete data collection from patients on study procedure, adverse events, follow-up imaging assessment, and tumor recurrence assessment elements. Data completeness feasibility will be considered to be met if these elements are collected in > 90% of enrolled patients.
Up to 5 Years
Study Safety
Time Frame: Day of procedure and within 1-month post-procedure (+/- 7 days)
Study safety will be defined as ≤ 10% of patients having experienced serious adverse events that are either possibly or definitely related to the 3-step procedure (i.e., ≤ 2 patients in the entire study) AND ≤ 15% of patients experiencing moderate or severe adverse events (i.e., the Common Terminology Criteria for Adverse Events v 5.0) (CTCAE) Grades 3-5 that are either possibly or probably related to the 3-step procedure (i.e., ≤ 3 patients in the entire study). For purposes of this study, cancer recurrence will be identified as a serious adverse event due to its life-threatening nature. All patients that begin the 3-step procedure will be included in the safety analysis.
Day of procedure and within 1-month post-procedure (+/- 7 days)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Feasibility Outcomes - Removal of biopsy clip
Time Frame: Within 1 month post procedure (+/- 7 days)
Removal of the cryoablation biopsy clip from the central target lesion will be analyzed as the proportion of patients who had clip removed relative to all patients who participated in the study. Successful targeting and removal of the cryoablation biopsy clip in ≥ 90% of patients who participated in the study is the threshold for this feasibility outcome.
Within 1 month post procedure (+/- 7 days)
Feasibility Outcomes - Negative margins
Time Frame: Within 1 month post procedure (+/- 7 days)
Negative (clean) margins will be defined as no tumor seen in the surrounding tissue by pathological evaluation following the procedure. Negative margins will be analyzed as the proportion of patients with negative margins relative to all patients who participated in the study. Negative margins (as determined by biopsies of surrounding tissue upon pathological assessment) observed in ≥ 90% of patients who participate in the study is the threshold for this feasibility outcome.
Within 1 month post procedure (+/- 7 days)
Feasibility Outcomes - Local recurrence
Time Frame: 6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months
Local recurrence will be defined as evidence of invasive or in situ breast cancer in the ipsilateral breast or chest wall. Patients who develop clinical evidence of tumor recurrence in the remainder of the breast or chest wall will be recommended to have a biopsy of the suspicious lesion to confirm the diagnosis. If a biopsy is not performed for any reason, an imaging designation of BIRADS 4 and 5 will be considered evidence of disease recurrence. Given the challenges of reliably defining local recurrence vs. new primary, all recurrences in the ipsilateral breast will be considered in the analysis of local recurrence. Local recurrence will be evaluated in patients for 5 years after study procedure using Kaplan-Meier methods.
6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months
Patient satisfaction questionnaire - time
Time Frame: Within 7 days of procedure
Patient satisfaction related to the time necessary to complete the procedure will be evaluated via administration of a questionnaire. Patients will be asked to rate satisfaction of the time needed based on a 5-point scale ranging from 1 ("Very Dissatisfied") to 5 ("Very Satisfied"), such that higher scores are indicative of better satisfaction with the time needed to complete the procedure.
Within 7 days of procedure
Procedural Pain - questionnaire
Time Frame: Within 7 days of procedure
Pain associated with the procedure will be evaluated via administration of a questionnaire. Patients will be asked to rate pain associated with the procedure based on a 6-point scale ranging from 1 ("No pain") to 5 ("Worst pain possible"), such that lower scores are indicative of less pain severity in association with the procedure.
Within 7 days of procedure
Procedural symptoms - questionnaire
Time Frame: Within 7 days of procedure
Symptom severity associated with the procedure will be evaluated via administration of a questionnaire. Patients will be asked to rate the severity of their symptoms using a 4-point scale ranging from 1 ("Mild") to 4 ("Very Severe"), such that lower scores are indicative of less symptom severity associated with the procedure.
Within 7 days of procedure
Patient satisfaction with breasts - preoperatively
Time Frame: Within 7 days of procedure
Patient satisfaction with breasts prior to treatment will be evaluated using Version 2.0 of the Breast-Q 'Satisfaction with Breasts' module. The preoperative Breast-Q module consists of 4 questions which asks patients to describe how satisfied/dissatisfied they have been over the past week with their breasts. The 4 responses are rated using a 4-point scale ranging from 1 ("Very Dissatisfied") to 4 ("Very Satisfied"), yielding a raw sum score of 4-16. Raw Breast-Q sum scores are then converted using a validated "Equivalent Rasch Transformed Score" table ranging from 0-100 such that higher Rasch scores are indicative of a better outcome. If missing data comprises <50% of the scale's items, the mean of the missing items is inserted into the table.
Within 7 days of procedure
Patient satisfaction with breasts - postoperatively
Time Frame: Within 7 days of procedure and within 1 year (+/- 1 month) post procedure
Patient satisfaction with breasts and breast cancer treatment prior following the procedure will be evaluated using Version 2.0 of the Breast-Q breast cancer treatment (BCT) module. This Breast-Q module consists of 11 questions which ask patients to describe how satisfied/dissatisfied they have been over the past week with respect to their breasts and breast cancer treatment. The 11 responses are rated using a 4-point scale ranging from 1 ("Very Dissatisfied") to 4 ("Very Satisfied"), yielding an overall sum score of 11-44. Raw Breast-Q sum scores are then converted using a validated "Equivalent Rasch Transformed Score" table ranging from 0-100 such that higher Rasch scores are indicative of a better outcome. If missing data comprises <50% of the scale's items, the mean of the missing items is inserted into the table.
Within 7 days of procedure and within 1 year (+/- 1 month) post procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Montefiore Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Laura A Hodges, MD, Montefiore Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • Farante, G., et al., Advances and controversies in management of breast ductal carcinoma in situ (DCIS). Eur J Surg Oncol, 2022. 48(4): p. 736-741.
  • Cowell, C.F., et al., Progression from ductal carcinoma in situ to invasive breast cancer: revisited. Mol Oncol, 2013. 7(5): p. 859-69.
  • Sheaffer, W.W., et al., Predictive factors of upstaging DCIS to invasive carcinoma in BCT vs mastectomy. Am J Surg, 2019. 217(6): p. 1025-1029.
  • Wapnir, I.L., et al., Long-term outcomes of invasive ipsilateral breast tumor recurrences after lumpectomy in NSABP B-17 and B-24 randomized clinical trials for DCIS. J Natl Cancer Inst, 2011. 103(6): p. 478-88.
  • Sabel, M.S., et al., Cryoablation of early-stage breast cancer: work-in-progress report of a multi-institutional trial. Ann Surg Oncol, 2004. 11(5): p. 542-9.
  • Erinjeri, J.P. and T.W. Clark, Cryoablation: mechanism of action and devices. J Vasc Interv Radiol, 2010. 21(8 Suppl): p. S187-91.
  • Ward, R.C., A.P. Lourenco, and M.B. Mainiero, Ultrasound-Guided Breast Cancer Cryoablation. AJR Am J Roentgenol, 2019. 213(3): p. 716-722.
  • Truesdale, M.D., et al., Comparison of two core biopsy techniques before and after laparoscopic cryoablation of small renal cortical neoplasms. JSLS, 2011. 15(4): p. 509-16.
  • Fine, R.E., et al., Cryoablation Without Excision for Low-Risk Early-Stage Breast Cancer: 3-Year Interim Analysis of Ipsilateral Breast Tumor Recurrence in the ICE3 Trial. Ann Surg Oncol, 2021. 28(10): p. 5525-5534.
  • Hughes, K.S., et al., Lumpectomy plus tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer. N Engl J Med, 2004. 351(10): p. 971-7.
  • Kunkler, I.H., et al., Breast-conserving surgery with or without irradiation in women aged 65 years or older with early breast cancer (PRIME II): a randomised controlled trial. Lancet Oncol, 2015. 16(3): p. 266-73.
  • Grimm, L.J., et al., Ductal Carcinoma in Situ: State-of-the-Art Review. Radiology, 2022. 302(2): p. 246-255.
  • Strom, C., L.S. Rasmussen, and F.E. Sieber, Should general anaesthesia be avoided in the elderly? Anaesthesia, 2014. 69 Suppl 1(Suppl 1): p. 35-44.
  • Poullain, F., et al., Percutaneous cryoablation of osteoblastoma in the proximal femur. Skeletal Radiol, 2020. 49(9): p. 1467-1471.
  • Ushijima, Y., et al., Diagnostic accuracy of percutaneous core biopsy before cryoablation for small-sized renal cell carcinoma. Diagn Interv Radiol, 2023. 29(6): p. 800-804.
  • Poplack, S.P., et al., A Pilot Study of Ultrasound-Guided Cryoablation of Invasive Ductal Carcinomas up to 15 mm With MRI Follow-Up and Subsequent Surgical Resection. AJR Am J Roentgenol, 2015. 204(5): p. 1100-8.
  • Littrup, P.J., et al., Cryotherapy for breast cancer: a feasibility study without excision. J Vasc Interv Radiol, 2009. 20(10): p. 1329-41.
  • Holmes, D. and G. Iyengar, Breast Cancer Cryoablation in the Multidisciplinary Setting: Practical Guidelines for Patients and Physicians. Life (Basel), 2023. 13(8).

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 27, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-17267

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings