Overview

This trial is active, not recruiting.

Conditions neoplasms, carcinoma
Treatment ct-guided percutaneous irreversible electroporation
Sponsor Yueyong Xiao
Start date October 2015
End date December 2016
Trial size 20 participants
Trial identifier NCT02567734, CHN-PLAGH-YY-001

Summary

Irreversible electroporation (IRE) is an emerging nonthermal focal ablation technique that uses a series of short but intense electric pulses delivered by NanoKnife generator through paired electrodes into a targeted region of tissue, inducing the cells death by apoptosis through irreversibly disrupting cellular membrane integrity. This study aimed to investigate the safety and efficacy of CT-guided percutaneous irreversible electroporation(IRE) in the treatment of patients with locally advanced tumors in different anatomical position.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
In this group,eligible patients were selected to receive the CT-guided percutaneous irreversible electroporation ablation.
ct-guided percutaneous irreversible electroporation NanoKnife
Patients undergo the irreversible electroporation ablation that induce protracted cell death by apoptosis through cell membrane perforation.All these procedures will be performed under the guide of Big bore multislice spiral CT scanning system.

Primary Outcomes

Measure
effective rate of IRE ablation
time frame: up to 12 months after the procedures

Secondary Outcomes

Measure
1-year survival rates
time frame: up to 12 months after the procedures
complication rate
time frame: During the procedure or up to 12 months after the ablation procedure

Eligibility Criteria

Male or female participants of any age.

Inclusion Criteria: 1. Histologically confirmed locally advanced solid tumor. 2. Unresectable tumors or the patient refused surgical therapy. 3. Patients in good health conditions can receive general anesthesia. 4. Patients with good compliance can cooperate with doctors for related tests and the regular follow-up. Exclusion Criteria: 1. Targeted tissues that metallic wallstents or metallics were implanted. 2. With heart pacemaker or be allergic to contrast medium that can not have related imaging examinations. 3. With bleeding and psychiatric disorders. 4. Severe arrhythmia.

Additional Information

Official title Clinical Trials of CT-guided Percutaneous Irreversible Electroporation(IRE)in the Treatment of Patients With Locally Advanced Tumors:The Safety and Efficacy Assessment
Principal investigator Yueyong Xiao
Description This study is a multicenter, open-label trial that aimed to evaluate the safety and efficacy of CT-guided percutaneous irreversible electroporation(IRE)in the treatment of patients with locally advanced tumors. Investigators will screen eligible patients and examine them by imaging tests as well as serological examination before and after the IRE procedures to assess the result with the size,blood supply,metabolism of tumors,the change of blood test and treatment-related complications. Big bore multislice spiral CT with thickness 5 cm, 120kilovolt,and 250milliampere,ECG-gated device and anesthesia monitoring equipment were selected during these procedures. Imaging (performed by contrast enhanced CT scan) and serological follow-up was at postoperative day 3 and 1,3,6,12months. The primary endpoint is the effective rate of IRE,and the secondary endpoint is 1-year survival rate and the frequency of adverse events. The response of irreversible electroporation ablation will be assessed according to the different evaluation criterions based on Response Evaluation Criteria in Solid Tumors.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by Chinese PLA General Hospital.