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

Clinical Trials of CT-guided Percutaneous Irreversible Electroporation（IRE）in the Treatment of Patients With Locally Advanced Tumors：The Safety and Efficacy Assessment

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.

Study Overview

• Status: Unknown
• Conditions: Neoplasms; Carcinoma
• Intervention / Treatment: Procedure: CT-guided percutaneous irreversible electroporation

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 Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing, China, 100853
    • The Chinese PLA General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Irreversible electroporation; In this group，eligible patients were selected to receive the CT-guided percutaneous irreversible electroporation ablation.	Procedure: CT-guided percutaneous irreversible electroporation; 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.; Other Names: NanoKnife

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Yueyong Xiao
• Investigators: Principal Investigator: Yueyong Xiao, The Chinese PLA General Hospital

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: September 28, 2015
• First Submitted That Met QC Criteria: October 2, 2015
• First Posted (Estimate): October 5, 2015

Study Record Updates

• Last Update Posted (Estimate): December 28, 2015
• Last Update Submitted That Met QC Criteria: December 24, 2015
• Last Verified: October 1, 2015

More Information

Terms related to this study

• Keywords: carcinoma; cancer; neoplasms; ablation; irreversible electroporation; NanoKnife; Ablation Techniques
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: CHN-PLAGH-YY-001