NCT07439432

Stereotactic Guided Biopsy and Cryoablation

Stereotactic Guided Biopsy and Cryoablation of Breast Cancer

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Montefiore Medical Center · Academic / Other
• Sex: Female
• Age: 60 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-06-01
• Completion: 2027-06-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Regulatory

• FDA-regulated device study