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

Neoplasms Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02567734
• Other study ID #: CHN-PLAGH-YY-001
• Status: Active, not recruiting
• Phase: N/A
• First received: September 28, 2015
• Last updated: December 24, 2015
• Start date: October 2015
• Est. completion date: January 2017

Study information

• Verified date: October 2015
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China:Committee of medical ehthics of the Chinese PLA General Hospital
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: January 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Carcinoma
• Neoplasms

Intervention

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.

Locations

Country	Name	City	State
China	The Chinese PLA General Hospital	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Yueyong Xiao

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	1-year survival rates		up to 12 months after the procedures	No
Secondary	complication rate	the frequency of adverse events,including early and late complications	During the procedure or up to 12 months after the ablation procedure	Yes