Stereotactic Guided Biopsy and Cryoablation

NCT07439432 | Withdrawn DMC FDA Device

• 1 other identifier: 2025-17267
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Breast Cancer

Keywords

cryoablation

Outcome Measures

Primary Outcomes (4)

• Overall feasibility

  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

  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

  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

  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 Outcomes (8)

• Feasibility Outcomes - Removal of biopsy clip

  Within 1 month post procedure (+/- 7 days)

• Feasibility Outcomes - Negative margins

  Within 1 month post procedure (+/- 7 days)

• Feasibility Outcomes - Local recurrence

  6 months, 12 months, 18 months, 24 months, 36 months, 48 months, and 60 months

• Patient satisfaction questionnaire - time

  Within 7 days of procedure

• Procedural Pain - questionnaire

  Within 7 days of procedure

Study Arms (1)

Cryoablation

EXPERIMENTAL

Device: Stereotactic Guided Biopsy and Cryoablation

Interventions

Stereotactic Guided Biopsy and Cryoablation DEVICE

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.

Cryoablation

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• High-risk pathology (e.g., Grade 3, HER2+ status, Genomic high-risk score (if available)).

Sponsors & Collaborators

• Montefiore Medical Center: lead

Related Publications (18)

• 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.

  BACKGROUND

• Cowell, C.F., et al., Progression from ductal carcinoma in situ to invasive breast cancer: revisited. Mol Oncol, 2013. 7(5): p. 859-69.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Erinjeri, J.P. and T.W. Clark, Cryoablation: mechanism of action and devices. J Vasc Interv Radiol, 2010. 21(8 Suppl): p. S187-91.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Grimm, L.J., et al., Ductal Carcinoma in Situ: State-of-the-Art Review. Radiology, 2022. 302(2): p. 246-255.

  BACKGROUND

• 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.

  BACKGROUND

• Poullain, F., et al., Percutaneous cryoablation of osteoblastoma in the proximal femur. Skeletal Radiol, 2020. 49(9): p. 1467-1471.

  BACKGROUND

• 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.

  BACKGROUND

• 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.

  BACKGROUND

• Littrup, P.J., et al., Cryotherapy for breast cancer: a feasibility study without excision. J Vasc Interv Radiol, 2009. 20(10): p. 1329-41.

  BACKGROUND

• Holmes, D. and G. Iyengar, Breast Cancer Cryoablation in the Multidisciplinary Setting: Practical Guidelines for Patients and Physicians. Life (Basel), 2023. 13(8).

  BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Laura A Hodges, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: February 27, 2026
• Study Start: October 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share