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Brief Title: Percutaneous Irreversible Electroportion for Unresectable Breast Cancer
Official Title: Safety and Efficacy of Irreversible Electroporation (IRE) for Breast Cancer
Study ID: NCT02340858
Brief Summary: This trial is studying how well Irreversible Electroportion (IRE) therapy works in treating patients with breast cancer. IRE kills tumor cells by Electrical impulses creating nano-pore on the cell membrane and inducing target cell death.This may be an effective treatment for patients with unresectable breast cancer.
Detailed Description: This is a phase I/II non-randomized exploratory study. All fully eligible and registered patients will undergo imaging by mammography, ultrasound, and breast MRI. The primary and secondary objectives of the study are described below. OBJECTIVES Primary Treatment efficacy as measured by modified Response Evaluation Criteria In Solid Tumors (RECIST) criteria by Computed Tomography (CT) or Magnetic Resonance (MR) imaging. secondary Safety using Common Terminology Criteria for Adverse Events (CTCAE) Version 3.0 criteria. To describe the adverse events associated with IRE To prospectively gather pain assessment data on cryoablation and surgical resection Explore technical variables that may affect the success of IRE
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
FUDA Cancer Hospital, Guangzhou, Guangdong, China
Name: Lizhi l Niu
Affiliation: FUDA Cancer Hospital
Role: STUDY_DIRECTOR