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Spots Global Cancer Trial Database for Percutaneous Irreversible Electroportion for Unresectable Breast Cancer

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We do not endorse or review these studies in any way.

Trial Identification

Brief Title: Percutaneous Irreversible Electroportion for Unresectable Breast Cancer

Official Title: Safety and Efficacy of Irreversible Electroporation (IRE) for Breast Cancer

Study ID: NCT02340858

Conditions

Breast Cancer

Study Description

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

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

FUDA Cancer Hospital, Guangzhou, Guangdong, China

Contact Details

Name: Lizhi l Niu

Affiliation: FUDA Cancer Hospital

Role: STUDY_DIRECTOR

Useful links and downloads for this trial

Clinicaltrials.gov

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