Kidney CancerPhase 1/2NCT02298608
Efficacy and Safety of IRE for RMs
A Phase 1/2 study testing Nano Knife in people with Kidney Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
Background: Electroporation or electropermeabilisation is a novel technique with the potential to overcome the main disadvantages of thermal ablation. It utilizes electric pulses, traveling between two or more electrodes, to create 'nanopores' in the cell membrane. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Cancer
- What is being tested?
- Nano Knife
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2014to Dec 2016
- Phase
- Phase 1/2
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Solid, enhancing mass on cross sectional imaging
- Scheduled for a radical nephrectomy, open or laparoscopic.
- Signed informed consent
Who cannot join
- Irreversible bleeding disorders
- Inability/unwillingness to interrupt anticoagulation therapy
- Previous cryoablation, RFA or partial nephrectomy in affected kidney
- Anaesthesia Surgical Assignment (ASA), category ≤ IV
- ICD / pacemaker
- Severe cardiovascular disease in medical history
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Dept. Urology, Academic Medical Center, Amsterdam
Amsterdam
Prof. M. Pilar Laguna Pes, M.D. Ph.D., +31(0)20-5668637, m.p.lagunapes@amc.nl
Peter GK Wagstaff, M.D., +31(0)205666493, p.g.wagstaff@amc.nl
About this study
Official title: The Efficacy and Safety of Irreversible Electroporation for the Ablation of Renal Masses: A Prospective, Human, In-Vivo Study.
Background:
Electroporation or electropermeabilisation is a novel technique with the potential to overcome the main disadvantages of thermal ablation. It utilizes electric pulses, traveling between two or more electrodes, to create 'nanopores' in the cell membrane. If the applied current reaches a certain threshold these 'nanopores' become permanent resulting in cell death. The use of electric current means that IRE is not susceptible to 'thermal sink' leading to consistent ablation results. IRE ablation targets the cell membrane, sparing tissue architecture and minimizing damage to blood vessels, nerves and the renal collecting system.
Read more
The first in human studies have proven the safety of IRE for the ablation of small renal masses. However the efficacy of IRE through histopathological examination of an ablated renal tumour has not yet been studied, compromising the correct and scientific evaluation of this new technology.
Primary Objectives:
- To determine the efficacy of IRE ablation of renal masses , measured by histopathologic examination of the targeted tumour.
- To determine the safety of IRE ablation of renal masses, by evaluating device and procedural adverse events.
Secondary Objectives:
- To evaluate the efficacy of MRI in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation.
- To evaluate the efficacy of CEUS in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation.
Population:
10 patients, age ≥ 18 years, presenting with a solid enhancing mass, who are candidates for radical nephrectomy.
Intervention:
Eligible patients will receive IRE ablation of their renal mass 4 weeks prior to radical nephrectomy. Follow-up at one and four weeks post IRE will be performed using MRI and CEUS imaging. After radical nephrectomy histopathological examination will be performed to evaluate IRE ablation success.
Read the detailed description
Rationale:
The past decades have shown an increase in the incidence of small renal masses (SRM). At the moment laparoscopic partial nephrectomy is the 'golden standard' in treatment of SRMs. Thermal ablation techniques are indicated in patients who are poor surgical candidates or who have a predisposition to develop multiple tumours. Recent studies have shown thermal ablation techniques to have similar long-term oncologic results. Downsides to thermal ablation are the possible damage to vital structures in the vicinity of the ablation zone, e.g. collecting system or intestine, and unpredictable results due to difficulty in monitoring the ablation zone and 'thermal sink'.
Electroporation or electropermeabilisation is a novel technique with the potential to overcome the main disadvantages of thermal ablation. It utilizes electric pulses, traveling between two or more electrodes, to create 'nanopores' in the cell membrane. If the applied current reaches a certain threshold these 'nanopores' become permanent resulting in cell death. The use of electric current means that IRE is not susceptible to 'thermal sink' leading to consistent ablation results. IRE ablation targets the cell membrane, sparing tissue architecture and minimizing damage to blood vessels, nerves and the renal collecting system.
The first in human studies have proven the safety of IRE for the ablation of small renal masses. However the efficacy of IRE through histopathological examination of an ablated renal tumour has not yet been studied, compromising the correct and scientific evaluation of a new technology. This is the primary objective of this research project.
Objectives:
Primary Objectives:
- To determine the efficacy of IRE ablation of renal masses , measured by histopathologic examination of the targeted tumour.
- To determine the safety of IRE ablation of renal masses, by evaluating device and procedural adverse events.
Secondary Objectives:
- To evaluate the efficacy of MRI in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation.
- To evaluate the efficacy of CEUS in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation.
Study design:
This is a prospective, human, in-vivo pilot study. Study population: 10 patients, age ≥ 18 years, presented with a solid enhancing RM , who are candidates for radical nephrectomy.
Intervention:
Patients will receive IRE ablation of the RM, performed under general anaesthesia, 4 weeks before radical nephrectomy. Follow-up at one and four weeks post IRE will be performed using MRI and CEUS imaging. After radical nephrectomy histopathological examination will be performed to evaluate IRE ablation success.
Main study parameters/endpoints:
Primary endpoints:
- The efficacy of IRE ablation of renal masses , measured by histopathologic examination of the targeted tumour by an experienced genitourinary pathologist. Using immunehistochemical staining to evaluate cell viability.
- The safety of IRE ablation of renal masses, by evaluating device and procedural adverse events using CTCAE v4.0.
Secondary endpoints:
- The efficacy of MRI in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation. By comparing MRI imaging to the histopathological examination results of the resected material.
- The efficacy of CEUS in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation. By comparing CEUS imaging to the histopathological examination results of the resected material.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
There are no benefits for patients that participate in this study. Study participants will be exposed to additional risk when compared to standard treatment. They will have to undergo an additional procedure under general anaesthesia with muscle relaxation. The exposure to ionizing radiation during the procedure has been estimated at 32 mSv. Patients have to be informed about the risks of procedural complications. Information on the efficacy of IRE, proven histopathologically, is a vital step in order to progress to long term follow-up studies without tumour excision. So far no study has investigated the efficacy of IRE for the ablation of renal tumours in this manner.
- Conditions
- Kidney Cancer
- Being tested
- Nano Knife
- Keywords
- Renal mass, Kidney cancer, Irreversibel Electroporation, Ablation, Safety, Efficacy, IRE
- Medical subject headings
- Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nano KnifeDevice
Also called Irreversible Electroporation
Percutaneous, CT guided, ablation of renal mass
| Study group | Role | What they receive |
|---|---|---|
| Irreversible Electroporation | Experimental | Percutaneous, CT guided, Irreversible Electroporation of renal mass Receives: Device: Nano Knife |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficacy of IRE ablation of renal masses , measured by histopathologic examination of the targeted tumour by an experienced genitourinary pathologist. Using immunehistochemical staining to evaluate cell viability.
Measured: 1 month
Number of device and procedural adverse events using CTCAE v4.0.
Measured: 1 month
Secondary outcomes (2)
The efficacy of MRI in the imaging of ablation success
The efficacy of MRI in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation. By comparing MRI imaging to the histopathological examination results of the resected material.
Measured: 1 month
The efficacy of CEUS in the imaging of ablation success
The efficacy of CEUS in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation. By comparing CEUS imaging to the histopathological examination results of the resected material.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startJan 2014
- Primary completionJan 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney CancerStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The sponsor's other registered studies.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, P.G.K. Wagstaff, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Prof. M. Pilar Laguna Pes, M.D. Ph.D., Principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)Prof. Jean J de la Rosette, M.D. Ph.D., Study chair, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298608
- Sponsor's protocol ID
- NL 44785.018.13
- Status last verified
- Nov 2014
- First submitted
- 20 Nov 2014
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wagstaff PG, de Bruin DM, Zondervan PJ, Savci Heijink CD, Engelbrecht MR, van Delden OM, van Leeuwen TG, Wijkstra H, de la Rosette JJ, Laguna Pes MP. The efficacy and safety of irreversible electroporation for the ablation of renal masses: a prospective, human, in-vivo study protocol. BMC Cancer. 2015 Mar 22;15:165. doi: 10.1186/s12885-015-1189-x.
PubMed 25886058
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy and Safety of Irreversible Electroporation for the Ablation of Renal Masses: A Prospective, Human, In-Vivo Study.
- ClinicalTrials.gov ID
- NCT02298608
- Acronym / sponsor ID
- NL 44785.018.13
- Conditions
- Kidney Cancer
- Keywords
- Renal mass, Kidney cancer, Irreversibel Electroporation, Ablation, Safety, Efficacy, IRE
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- Jan 2014
- Primary completion
- Jan 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 24 Nov 2014 (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.
Background:
Electroporation or electropermeabilisation is a novel technique with the potential to overcome the main disadvantages of thermal ablation. It utilizes electric pulses, traveling between two or more electrodes, to create 'nanopores' in the cell membrane. If the applied current reaches a certain threshold these 'nanopores' become permanent resulting in cell death. The use of electric current means that IRE is not susceptible to 'thermal sink' leading to consistent ablation results. IRE ablation targets the cell membrane, sparing tissue architecture and minimizing damage to blood vessels, nerves and the renal collecting system.
The first in human studies have proven the safety of IRE for the ablation of small renal masses. However the efficacy of IRE through histopathological examination of an ablated renal tumour has not yet been studied, compromising the correct and scientific evaluation of this new technology.
Primary Objectives:
- To determine the efficacy of IRE ablation of renal masses , measured by histopathologic examination of the targeted tumour.
- To determine the safety of IRE ablation of renal masses, by evaluating device and procedural adverse events.
Secondary Objectives:
- To evaluate the efficacy of MRI in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation.
- To evaluate the efficacy of CEUS in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation.
Population:
10 patients, age ≥ 18 years, presenting with a solid enhancing mass, who are candidates for radical nephrectomy.
Intervention:
Eligible patients will receive IRE ablation of their renal mass 4 weeks prior to radical nephrectomy. Follow-up at one and four weeks post IRE will be performed using MRI and CEUS imaging. After radical nephrectomy histopathological examination will be performed to evaluate IRE ablation success.
Detailed description
Rationale:
The past decades have shown an increase in the incidence of small renal masses (SRM). At the moment laparoscopic partial nephrectomy is the 'golden standard' in treatment of SRMs. Thermal ablation techniques are indicated in patients who are poor surgical candidates or who have a predisposition to develop multiple tumours. Recent studies have shown thermal ablation techniques to have similar long-term oncologic results. Downsides to thermal ablation are the possible damage to vital structures in the vicinity of the ablation zone, e.g. collecting system or intestine, and unpredictable results due to difficulty in monitoring the ablation zone and 'thermal sink'.
Electroporation or electropermeabilisation is a novel technique with the potential to overcome the main disadvantages of thermal ablation. It utilizes electric pulses, traveling between two or more electrodes, to create 'nanopores' in the cell membrane. If the applied current reaches a certain threshold these 'nanopores' become permanent resulting in cell death. The use of electric current means that IRE is not susceptible to 'thermal sink' leading to consistent ablation results. IRE ablation targets the cell membrane, sparing tissue architecture and minimizing damage to blood vessels, nerves and the renal collecting system.
The first in human studies have proven the safety of IRE for the ablation of small renal masses. However the efficacy of IRE through histopathological examination of an ablated renal tumour has not yet been studied, compromising the correct and scientific evaluation of a new technology. This is the primary objective of this research project.
Objectives:
Primary Objectives:
- To determine the efficacy of IRE ablation of renal masses , measured by histopathologic examination of the targeted tumour.
- To determine the safety of IRE ablation of renal masses, by evaluating device and procedural adverse events.
Secondary Objectives:
- To evaluate the efficacy of MRI in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation.
- To evaluate the efficacy of CEUS in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation.
Study design:
This is a prospective, human, in-vivo pilot study. Study population: 10 patients, age ≥ 18 years, presented with a solid enhancing RM , who are candidates for radical nephrectomy.
Intervention:
Patients will receive IRE ablation of the RM, performed under general anaesthesia, 4 weeks before radical nephrectomy. Follow-up at one and four weeks post IRE will be performed using MRI and CEUS imaging. After radical nephrectomy histopathological examination will be performed to evaluate IRE ablation success.
Main study parameters/endpoints:
Primary endpoints:
- The efficacy of IRE ablation of renal masses , measured by histopathologic examination of the targeted tumour by an experienced genitourinary pathologist. Using immunehistochemical staining to evaluate cell viability.
- The safety of IRE ablation of renal masses, by evaluating device and procedural adverse events using CTCAE v4.0.
Secondary endpoints:
- The efficacy of MRI in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation. By comparing MRI imaging to the histopathological examination results of the resected material.
- The efficacy of CEUS in the imaging of ablation success, extend of the ablation zone, one and four weeks post IRE ablation. By comparing CEUS imaging to the histopathological examination results of the resected material.
Nature and extent of the burden and risks associated with participation, benefit and group relatedness:
There are no benefits for patients that participate in this study. Study participants will be exposed to additional risk when compared to standard treatment. They will have to undergo an additional procedure under general anaesthesia with muscle relaxation. The exposure to ionizing radiation during the procedure has been estimated at 32 mSv. Patients have to be informed about the risks of procedural complications. Information on the efficacy of IRE, proven histopathologically, is a vital step in order to progress to long term follow-up studies without tumour excision. So far no study has investigated the efficacy of IRE for the ablation of renal tumours in this manner.
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 | Device: Nano KnifePercutaneous, CT guided, Irreversible Electroporation of renal mass |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years
- Solid, enhancing mass on cross sectional imaging
- Scheduled for a radical nephrectomy, open or laparoscopic.
- Signed informed consent
Key exclusion criteria (6 listed)
- Irreversible bleeding disorders
- Inability/unwillingness to interrupt anticoagulation therapy
- Previous cryoablation, RFA or partial nephrectomy in affected kidney
- Anaesthesia Surgical Assignment (ASA), category ≤ IV
- ICD / pacemaker
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 |
|---|---|---|
| Nano KnifeAlso: Irreversible ElectroporationPercutaneous, CT guided, ablation of renal mass | Device | Irreversible Electroporation |
Primary outcome
The efficacy of IRE ablation of renal masses , measured by histopathologic examination of the targeted tumour by an experienced genitourinary pathologist. Using immunehistochemical staining to evaluate cell viability.
Time frame: 1 month
Number of device and procedural adverse events using CTCAE v4.0.
Time frame: 1 month
2 secondary outcomes
The efficacy of MRI in the imaging of ablation success
Time frame: 1 month
The efficacy of CEUS in the imaging of ablation success
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
- Derived from this study: PubMed 25886058Wagstaff PG, de Bruin DM, Zondervan PJ, Savci Heijink CD, Engelbrecht MR, van Delden OM, van Leeuwen TG, Wijkstra H, de la Rosette JJ, Laguna Pes MP. The efficacy and safety of irreversible electroporation for the ablation of renal masses: a prospective, human, in-vivo study protocol. BMC Cancer. 2015 Mar 22;15:165. doi: 10.1186/s12885-015-1189-x.
Related trials for Kidney Cancer
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 3
A Study of Belzutifan (MK-6482) in Combination With Lenvatinib Versus Cabozantinib for Treatment of Renal Cell Carcinoma (MK-6482-011)
Carcinoma, Renal Cell
RecruitingPhase 2/3
Testing the Role of DNA Released From Tumor Cells Into the Blood in Guiding the Use of Immunotherapy After Surgical Removal of the Bladder, Kidney, Ureter, and Urethra for Urothelial Cancer Treatment, MODERN Study
Muscle Invasive Bladder Urothelial Carcinoma, Muscle Invasive Renal Pelvis Urothelial Carcinoma
Not yet recruitingPhase 2
Toripalimab and Lenvatinib With or Without SBRT Before Surgery for Non-Clear Cell Kidney Cancer
Nonmetastatic Locally Advanced Non-Clear Cell Renal Cell Carcinoma
Not yet recruitingPhase 1
A Study to Assess the Pharmacokinetics and Safety of Revumenib in Participants With Advanced Cancer and Hepatic or Renal Impairment
Relapsed/Refractory (R/R) Hematologic Malignancies, Acute Leukemia
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.
Prof. M. Pilar Laguna Pes, M.D. Ph.D. principal investigator
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Prof. Jean J de la Rosette, M.D. Ph.D. study chair
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Nano Knife in people with Kidney Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 6 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 24 Nov 2014. 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 Netherlands. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Contact Prof. M. Pilar Laguna Pes, M.D. Ph.D. (+31(0)20-5668637, m.p.lagunapes@amc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The efficacy of IRE ablation of renal masses , measured by histopathologic examination of the targeted tumour by an experienced genitourinary pathologist. Using immunehistochemical staining to evaluate cell viability. (time frame: 1 month). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02298608, which also lists 1 linked publication.
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 24 Nov 2014.