Clinical trial · Interventional
Stereotactic Guided Biopsy and Cryoablation
Stereotactic Guided Biopsy and Cryoablation of Breast Cancer
NCT07439432CI-TRIAL-00104286withdrawnN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study never approved by the Albert Einstein College of Medicine IRB.
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Stereotactic Guided Biopsy and Cryoablation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Cryoablation
- interventionNames
- Device: Stereotactic Guided Biopsy and Cryoablation
Primary outcomes (4)
- measure
- Overall feasibility
- timeFrame
- Up to 5 Years
- description
- 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.
- measure
- Feasibility - Procedure Completeness
- timeFrame
- Within 1 month post procedure (+/- 7 days)
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 60 Years
Show eligibility criteria text
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)).
References
Publications (18)
- BACKGROUNDFarante G, Toesca A, Magnoni F, Lissidini G, Vila J, Mastropasqua M, Viale G, Penco S, Cassano E, Lazzeroni M, Bonanni B, Leonardi MC, Ripoll-Orts F, Curigliano G, Orecchia R, Galimberti V, Veronesi P. Advances and controversies in management of breast ductal carcinoma in situ (DCIS). Eur J Surg Oncol. 2022 Apr;48(4):736-741. doi: 10.1016/j.ejso.2021.10.030. Epub 2021 Nov 9. PMID 34772587
- BACKGROUNDCowell CF, Weigelt B, Sakr RA, Ng CK, Hicks J, King TA, Reis-Filho JS. Progression from ductal carcinoma in situ to invasive breast cancer: revisited. Mol Oncol. 2013 Oct;7(5):859-69. doi: 10.1016/j.molonc.2013.07.005. Epub 2013 Jul 12. PMID 23890733
- BACKGROUNDSheaffer WW, Gray RJ, Wasif N, Stucky CC, Cronin PA, Kosiorek HE, Basu A, Pizzitola VJ, Patel B, Giurescu ME, Lorans R, McCullough AE, Ocal IT, Pockaj BA. Predictive factors of upstaging DCIS to invasive carcinoma in BCT vs mastectomy. Am J Surg. 2019 Jun;217(6):1025-1029. doi: 10.1016/j.amjsurg.2018.12.069. Epub 2019 Feb 23. PMID 30879795
- BACKGROUNDWapnir IL, Dignam JJ, Fisher B, Mamounas EP, Anderson SJ, Julian TB, Land SR, Margolese RG, Swain SM, Costantino JP, Wolmark N. 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 Mar 16;103(6):478-88. doi: 10.1093/jnci/djr027. Epub 2011 Mar 11. PMID 21398619
- BACKGROUNDSabel MS, Kaufman CS, Whitworth P, Chang H, Stocks LH, Simmons R, Schultz M. Cryoablation of early-stage breast cancer: work-in-progress report of a multi-institutional trial. Ann Surg Oncol. 2004 May;11(5):542-9. doi: 10.1245/ASO.2004.08.003. PMID 15123465
- BACKGROUNDErinjeri JP, Clark TW. Cryoablation: mechanism of action and devices. J Vasc Interv Radiol. 2010 Aug;21(8 Suppl):S187-91. doi: 10.1016/j.jvir.2009.12.403. PMID 20656228