NeoplasmsNCT02567734
Clinical Trials of CT-guided Percutaneous Irreversible Electroporation（IRE）in the Treatment of Patients With Locally Advanced Tumors
A study testing CT-guided percutaneous irreversible electroporation in people with Neoplasms and Carcinoma, run by Yueyong Xiao at 1 site in China.
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… Read more about this study
- Who is it for?
- Any age
- What is being tested?
- CT-guided percutaneous irreversible electroporation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Oct 2015to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histologically confirmed locally advanced solid tumor.
- Unresectable tumors or the patient refused surgical therapy.
- Patients in good health conditions can receive general anesthesia.
- Patients with good compliance can cooperate with doctors for related tests and the regular follow-up.
Who cannot join
- Targeted tissues that metallic wallstents or metallics were implanted.
- With heart pacemaker or be allergic to contrast medium that can not have related imaging examinations.
- With bleeding and psychiatric disorders.
- Severe arrhythmia.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Being tested
- CT-guided percutaneous irreversible electroporation
- Keywords
- irreversible electroporation, ablation, neoplasms, cancer, carcinoma, NanoKnife, Ablation Techniques
- Medical subject headings
- Neoplasms, Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CT-guided percutaneous irreversible electroporationProcedure or surgery
Also called 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.
| Study group | Role | What they receive |
|---|---|---|
| Irreversible electroporation | Experimental | In this group，eligible patients were selected to receive the CT-guided percutaneous irreversible electroporation ablation. Receives: Procedure: CT-guided percutaneous irreversible electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 12 months after the procedures
Secondary outcomes (2)
1-year survival rates
Measured: up to 12 months after the procedures
complication rate
the frequency of adverse events，including early and late complications
Measured: During the procedure or up to 12 months after the ablation procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2016 (estimated)
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NeoplasmsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yueyong Xiao
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yueyong Xiao, Chinese PLA General Hospital
- Investigators
- Yueyong Xiao, Principal investigator, The Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02567734
- Sponsor's protocol ID
- CHN-PLAGH-YY-001
- Status last verified
- Oct 2015
- First submitted
- 28 Sep 2015
- Last updated
- 28 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02567734
- Acronym / sponsor ID
- CHN-PLAGH-YY-001
- Keywords
- irreversible electroporation, ablation, neoplasms, cancer, carcinoma, NanoKnife, Ablation Techniques
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Yueyong XiaoUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Jan 2017 (estimated)
- First posted
- 5 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Irreversible electroporation | Experimental | Procedure: CT-guided percutaneous irreversible electroporationIn this group，eligible patients were selected to receive the CT-guided percutaneous irreversible electroporation ablation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed locally advanced solid tumor.
- Unresectable tumors or the patient refused surgical therapy.
- Patients in good health conditions can receive general anesthesia.
- Patients with good compliance can cooperate with doctors for related tests and the regular follow-up.
Key exclusion criteria (4 listed)
- Targeted tissues that metallic wallstents or metallics were implanted.
- With heart pacemaker or be allergic to contrast medium that can not have related imaging examinations.
- With bleeding and psychiatric disorders.
- Severe arrhythmia.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CT-guided percutaneous irreversible electroporationAlso: NanoKnifePatients 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. | Procedure or surgery | Irreversible electroporation |
Primary outcome
effective rate of IRE ablation
Time frame: 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.
2 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yueyong Xiao principal investigator
The Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CT-guided percutaneous irreversible electroporation in people with Neoplasms and Carcinoma, run by Yueyong Xiao at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effective rate of IRE ablation (time frame: up to 12 months after the procedures). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Dec 2015.