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

NCT ID: NCT02567734

Last Updated: 2015-12-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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.

Conditions

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Neoplasms Carcinoma

Keywords

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irreversible electroporation ablation neoplasms cancer carcinoma NanoKnife Ablation Techniques

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Irreversible electroporation

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

Group Type EXPERIMENTAL

CT-guided percutaneous irreversible electroporation

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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NanoKnife

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Yueyong Xiao

OTHER

Sponsor Role lead

Responsible Party

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Yueyong Xiao

Director of the Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Yueyong Xiao

Role: PRINCIPAL_INVESTIGATOR

The Chinese PLA General Hospital

Locations

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The Chinese PLA General Hospital

Beijing, , China

Site Status

Countries

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China

Other Identifiers

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CHN-PLAGH-YY-001

Identifier Type: -

Identifier Source: org_study_id