NCT02340858

Percutaneous Irreversible Electroportion for Unresectable Breast Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Fuda Cancer Hospital, Guangzhou · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DEVICE	NanoKnife LEDC System	Irreversible electroporation (IRE) is a method to induce irreversible disruption of cell membrane integrity (loss of cell homeostasis) resulting in cell death without the need for additional pharmacological injury. Because IRE is a non-thermal technique, changes associated with perfusion-mediated tissue cooling (or heating) are not relevant. While cells in the ablation region are destroyed, the underlying extracellular matrix is not damaged thus allowing tissues in the ablation zone to heal normally.

Timeline

• Start date: 2015-01-01
• Primary completion: 2020-12-01
• Completion: 2021-01-01
• First posted: 2015-01-19
• Last updated: 2021-09-05

Locations

1 site across 1 country: China