Clinical Trials of CT-guided Percutaneous Irreversible Electroporation（IRE）in the Treatment of Patients With Locally Advanced Tumors

Not Applicable

• Conditions: Neoplasms; Carcinoma
• Interventions: Procedure: CT-guided percutaneous irreversible electroporation

• Registration Number: NCT02567734
• Lead Sponsor: Yueyong Xiao

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2015-09-28
• Status Verified: 2015-10
• Study Start: 2015-10
• Study First Submitted QC: 2015-10-02
• Study First Posted: 2015-10-05
• Last Update Submitted: 2015-12-24
• Last Update Posted: 2015-12-28
• Primary Completion: 2016-12
• Study Completion: 2017-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Irreversible electroporation	CT-guided percutaneous irreversible electroporation	In this group，eligible patients were selected to receive the CT-guided percutaneous irreversible electroporation ablation.

Primary Outcome Measures

Name	Time	Method
effective rate of IRE ablation	up to 12 months after the procedures	The procedure-related result will be assess by the size，blood supply，metabolism of the tumors. The changes of blood test are also considerable.

Secondary Outcome Measures

Name	Time	Method
1-year survival rates	up to 12 months after the procedures
complication rate	During the procedure or up to 12 months after the ablation procedure	the frequency of adverse events，including early and late complications

Trial Locations

Locations (1)

The Chinese PLA General Hospital; 🇨🇳 Beijing, China