Breast Cancer Clinical Trial
Official title:
A Phase II Trial Exploring the Success of Cryoablation Therapy in the Treatment of Invasive Breast Carcinoma
This phase II trial is studying how well cryoablation therapy works in treating patients with invasive ductal breast cancer. Cryoablation kills tumor cells by freezing them. This may be an effective treatment for patients with invasive ductal breast cancer.
This is a phase II non-randomized exploratory study. All fully eligible and registered
patients will undergo imaging by mammography, ultrasound, and breast MRI. Patients will then
undergo complete surgical resection of the primary tumor. The primary and secondary
objectives of the study are described below.
OBJECTIVES:
Primary
- To determine the rate of complete tumor ablation in patients treated with cryoablation,
with complete tumor ablation defined as no remaining invasive or in situ carcinoma
present upon pathological examination of the targeted lesion
Secondary
- To evaluate the negative predictive value of MRI in the post-ablation setting to
determine residual in situ or invasive breast carcinoma
- To describe the adverse events associated with cryoablation
- To prospectively gather pain assessment data on cryoablation and surgical resection
- Explore technical variables that may affect the success of cryoablation
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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