Renal TumorIRENCT02335827
Irreversible Electroporation(IRE) For Unresectable Renal Tumors
A study testing irreversible electroporation in people with Renal Tumor, run by Fuda Cancer Hospital, Guangzhou at 1 site in China.
Trial summary
The purpose of this study is to investigate the safety and efficacy of irreversible electroporation (IRE) for unresectable renal tumors. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Renal Tumor
- What is being tested?
- irreversible electroporation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2015to 1 Jan 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- unresectable kidney tumors
- patients refused surgical therapy
- Karnofsky-index >70%
- Age ≥ 18 and ≤ 80 years
- life expectancy ≥ 12 month
- compliance of the patient taking part in a study
- informed consent
Who cannot join
- violation against one or more inclusion criteria
- an estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73 m2
- QT-interval >550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ECG-synchronisation unfeasible
- active infection or severe health interference, that make taking part in a study unfeasible
- pregnancy, lactation period
- general contraindications for anesthesia, endotracheal anesthesia and muscle relaxation
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- psychiatric disorders that make taking part in a study or giving informed consent unfeasible
- haemorrhage, impossible intermission of taking blood thinner, untreatable thrombophilia
- thromboplastin time ≤50 %, thrombocytes ≤50 Gpt/L; partial thromboplastin time >50
- untreated urinary retention
- severe hepatic dysfunction
- any other clinically important renal, hematological, metabolic, neurological, gastrointestinal, hepatic or pulmonary disorders or dysfunctions preventing study participation (investigator's assessment)
- taking part in another clinical study for renal tumor.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Irreversible Electroporation (IRE) for Unresectable Renal Tumors: Phase I and Phase II Clinical Trial
The purpose of this study is to investigate the safety and efficacy of irreversible electroporation (IRE) for unresectable renal tumors.
Read the detailed description
By enrolling patients with renal tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous or intraoperative IRE for renal tumors .
- Conditions
- Renal Tumor
- Being tested
- irreversible electroporation
- Keywords
- irreversible electroporation, renal tumor
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
irreversible electroporationProcedure or surgery
Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | irreversible electroporation with voltage in level A for renal tumors Receives: Procedure: irreversible electroporation |
| Group B | Experimental | irreversible electroporation with voltage in level B for renal tumors Receives: Procedure: irreversible electroporation |
| Group C | Experimental | irreversible electroporation with voltage in level C for renal tumors Receives: Procedure: irreversible electroporation |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse effects
adverse effects measured by such as abdominal bleeding, continuous abdominal pain, renal failure, et al.
Measured: 1 month
Quality of Life (QoL)
Quality of Life assessed as WHOQOL-BREF.
Measured: 2 months
procedural compliance
compliance will be analyzed by 3 months of follow-up post procedure.
Measured: 3 months
Secondary outcomes (2)
Recurrence rate
efficacy assessment by percentage of lesions that show no sign of recurrence 12 months after the initial IRE procedure) of IRE for renal tumor via cross-sectional imaging and pathological examination.
Measured: 12 months
Voltage (A minimum and maximum range of voltage for safe and effective IRE)
A minimum and maximum range of voltage for safe and effective IRE will be analyzed for optimal choice.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2015 (estimated)
- Study start1 Jan 2015
- Primary completion20 May 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal TumorStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fuda Cancer Hospital, Guangzhou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lizhi Niu, PHD, Study chair, Fuda Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02335827
- Sponsor's protocol ID
- IRE-001
- Acronym
- IRE
- Status last verified
- Jun 2020
- First submitted
- 2 Jan 2015
- Last updated
- 5 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Irreversible Electroporation (IRE) for Unresectable Renal Tumors: Phase I and Phase II Clinical Trial
- ClinicalTrials.gov ID
- NCT02335827
- Acronym / sponsor ID
- IRE / IRE-001
- Conditions
- Renal Tumor
- Keywords
- irreversible electroporation, renal tumor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Fuda Cancer Hospital, GuangzhouUniversity, hospital or other
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 20 May 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 12 Jan 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.
The purpose of this study is to investigate the safety and efficacy of irreversible electroporation (IRE) for unresectable renal tumors.
Detailed description
By enrolling patients with renal tumors adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of percutaneous or intraoperative IRE for renal tumors .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Procedure: irreversible electroporationirreversible electroporation with voltage in level A for renal tumors |
| Group B | Experimental | Procedure: irreversible electroporationirreversible electroporation with voltage in level B for renal tumors |
| Group C | Experimental | Procedure: irreversible electroporationirreversible electroporation with voltage in level C for renal tumors |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- unresectable kidney tumors
- patients refused surgical therapy
- Karnofsky-index >70%
- Age ≥ 18 and ≤ 80 years
- life expectancy ≥ 12 month
Key exclusion criteria (13 listed)
- violation against one or more inclusion criteria
- an estimated glomerular filtration rate (eGFR) of < 30 mL/min/1.73 m2
- QT-interval >550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ECG-synchronisation unfeasible
- active infection or severe health interference, that make taking part in a study unfeasible
- pregnancy, lactation period
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 |
|---|---|---|
| irreversible electroporationPercutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors | Procedure or surgery | Group A, Group B, Group C |
Primary outcome
adverse effects
Time frame: 1 month
adverse effects measured by such as abdominal bleeding, continuous abdominal pain, renal failure, et al.
Quality of Life (QoL)
Time frame: 2 months
Quality of Life assessed as WHOQOL-BREF.
procedural compliance
Time frame: 3 months
compliance will be analyzed by 3 months of follow-up post procedure.
2 secondary outcomes
Recurrence rate
Time frame: 12 months
Voltage (A minimum and maximum range of voltage for safe and effective IRE)
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
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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.
Lizhi Niu, PHD study chair
Fuda Cancer 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 irreversible electroporation in people with Renal Tumor, run by Fuda Cancer Hospital, Guangzhou 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 7 inclusion and 13 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: finished, as of the sponsor's last update on 5 Sep 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
adverse effects (time frame: 1 month). The study lists 3 primary outcomes in all. 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 5 Sep 2021.