Kidney TumorPhase 1/2IRENENCT01967407
IReversible Electroporation of Kidney Tumors Before Partial Nephrectomy.
A Phase 1/2 study testing Irreversible Electroporation (IRE) in people with Kidney Tumor and Renal Cell Cancer, run by University of Magdeburg at 4 sites in Germany.
Trial summary
The aim of the study is the evaluation of the ablation efficiency of the percutaneous irreversible electroporation (IRE) as primary ablation therapy of locally confined renal cell carcinoma (≤4cm, see inclusion and exclusion criteria). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Tumor, Renal Cell Cancer
- What is being tested?
- Irreversible Electroporation (IRE)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 4 sitesGermany
- Study dates
- Oct 2013to Jan 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
- one or more localized, resectable kidney tumors (≤4 cm) suspicious of malignancy or histology -proven renal cell cancer (RCC)
- patients desire for therapy and surgical therapy
- Karnofsky-index >70%
- Age ≥ 18 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
- cardial pacemaker or other electrical implants
- QT-interval >550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ECG-synchronisation unfeasible
- known cardial ejection fraction < 30% or NYHA III or III-IV
- known epilepsy
- second malignancy (except basal-cell carcinoma and cervical carcinoma in situ)
Show all 25Show fewer
- immunosuppression or HIV-positive patients
- active infection or severe health interference, that make taking part in a study unfeasible
- pregnancy, lactation period, no contraception
- metastatic disease
- palliative status
- running or executed RCC therapy
- taking part in another clinical study for RCC
- inoperable
- rejection of interventional or surgical therapy by the patient
- circulatory instability
- general contraindications for anesthesia, endotracheal anesthesia and muscle relaxation
- 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
- MRI incompatibility
- metal implants <1 cm closed to the kidney / kidney tumor
- contraindication for biopsy and punction of the renal tumor under CT-guidance
- untreated urinary retention
- renal pelvis tumor, suspected transitional cell cancer
Trial locations and contacts
4 sites in 1 country.
Germany4 sites, 4 recruiting
- Recruiting
MVZ Hanse Histologikum GmbH Hamburg
Hamburg, 22547
Jens Köllermann, PD Dr. med., 0049-40-707085200, koellermann@pathologie-hh.de
Jens Köllermann, PD Dr. med
- Recruiting
Department of Pathology University Hospital Otto-von-Guericke-University Magdeburg
Magdeburg, Saxony-Anhalt, 39120
Sandra Böttcher, Dr.
Albert Roessner, Prof.
- Recruiting
Department of Radiology University Hospital Otto-von-Guericke-University Magdeburg
Magdeburg, Saxony-Anhalt, 39120
Jens Ricke, Prof.
Frank Fischbach, Prof.
- Recruiting
Department of Urology University Hospital Otto-von-Guericke-University Magdeburg
Magdeburg, Saxony-Anhalt, 39120
Markus Porsch, Dr.
Andreas Janitzky, Dr.
About this study
Official title: Prospective, Monocentric, Clinical Phase-I/II Study of the Effectiveness of the Percutaneous Irreversible Electroporation (IRE) of Locally Confined Kidney Tumors (Renal Cell Carcinomas).
The aim of the study is the evaluation of the ablation efficiency of the percutaneous irreversible electroporation (IRE) as primary ablation therapy of locally confined renal cell carcinoma (≤4cm, see inclusion and exclusion criteria).
The ablation success will be proofed by magnet resonance imaging (MRI) and histologically after partial kidney resection or nephrectomy 4 weeks after IRE. Hypotheses: Kidney tumors ≤4cm can be ablated completely by percutaneous IRE. Surrounded structures and renal tissue can be preserved.
Read the detailed description
Health Condition or Problem studied:
- International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD10): C64 - Malignant neoplasm of kidney, except renal pelvis
- ICD10: D41.0 - Neoplasm of uncertain or unknown behaviour: Kidney
Interventions/Observational Groups Arm 1:
- Initial diagnostical examination of the renal mass.
- If any extended diagnostical examination for treatment planning.
- Day -29 to -1: Recruitment.
- Day -1: MRI of the kidney, Karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment.
- Day 0: Percutaneous diagnostical biopsy with histopathological investigation and therapeutically, CT- and/or ultrasound-guided, ECG-synchronized irreversible electroporation (IRE) of the kidney tumor in endotracheal anaesthesia und muscle relaxation. Use of 1-6 IRE probes with 90-100 pulses of 1500-3000 volts und 20-50 amperes each.
- Day 1-7: Postinterventional follow-up: MRI of the kidneys, Karnofsky, physical examination, blood chemistry, urosonography, life quality assessment.
- Day 27: Postinterventional follow-up: MRI of the kidneys, Karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment.
- Day 28: Open surgery partial kidney resection or tumor nephrectomy of the IRE treated kidney resp. kidney tumor region with histopathological investigation.
- Day 29-37: Postoperative follow-up: physical examination, blood chemistry, urosonography, life quality assessment.
- Day 112: Study-Follow-up: MRI of the kidneys, Karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment. Termination of the study.
- Study closed, Individual follow-up due to the European Association of Urology guideline.
Recruitment:
- (Anticipated or Actual) Date of First Enrollment: 2013/10/14
- Planned/Actual: Opened
- Target Sample Size: 20
- Monocentric/Multicentric trial: Monocentric trial
- National/International: National
- Conditions
- Kidney Tumor, Renal Cell Cancer
- Being tested
- Irreversible Electroporation (IRE)
- Keywords
- kidney tumor, renal cell cancer, RCC, irreversible electroporation, IRE, partial kidney resection, percutaneous, ablation, IRENE
- 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 Electroporation (IRE)Procedure or surgery
Also called NanoKnife (Tissue Ablation) System, AngioDynamics Inc.
Percutaneous CT-fluoroscopic-guided Irreversible Electroporation.
| Study group | Role | What they receive |
|---|---|---|
| renal tumor <4cm, suspected RCC | Experimental | Intervention/ Time point: Irreversible Electroporation at day 0 of each patient. Receives: Procedure: Irreversible Electroporation (IRE) |
What is being measured
The primary outcome is the main question the study is designed to answer.
analysis of ablation effectiveness of non-metastatic renal tumors <4cm 28 days by after irreversible electroporation (NanoKnife, AngioDynamics Inc.) by histopathological examination of partial kidney resection specimens
onco-therapeutic effectiveness, measured against persistent active tumor / cancer cells by histopathological and magnet resonance imaging analysis
Measured: 28 days
Secondary outcomes (1)
safety
- adverse effects
- Assessment of the procedural compliance
- Assessment of the Quality of Life (QoL)
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2013 (estimated)
- Study startOct 2013
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Kidney 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Magdeburg
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Johann J. Wendler, MD, University of Magdeburg
- Investigators
- Uwe- B. Liehr, Dr. med., Principal investigator, Department of Urology, University Magdeburg, Germany.Martin Schostak, Prof. Dr., Study director, Department of Urology, University Magdeburg, GermanyJohann J. Wendler, Dr. med., Principal investigator, Department of Urology, University Magdeburg, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967407
- Sponsor's protocol ID
- DE-UKMD-URO-001
- Other IDs
- DRKS00004266, U1111-1140-0415, DRKS00004266, EUDAMED-No.: CIV-12-04-006021, 00020520
- Acronym
- IRENE
- Status last verified
- Nov 2014
- First submitted
- 15 Oct 2013
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Liehr UB, Wendler JJ, Blaschke S, Porsch M, Janitzky A, Baumunk D, Pech M, Fischbach F, Schindele D, Grube C, Ricke J, Schostak M. [Irreversible electroporation: the new generation of local ablation techniques for renal cell carcinoma]. Urologe A. 2012 Dec;51(12):1728-34. doi: 10.1007/s00120-012-3038-8. German.
PubMed 23139026Jiang C, Davalos RV, Bischof JC. A review of basic to clinical studies of irreversible electroporation therapy. IEEE Trans Biomed Eng. 2015 Jan;62(1):4-20. doi: 10.1109/TBME.2014.2367543.
PubMed 25389236Wendler JJ, Porsch M, Fischbach F, Pech M, Schostak M, Liehr UB. Letter to the Editor Concerning "Irreversible Electroporation (IRE) Fails to Demonstrate Efficacy in a Prospective Multicenter Phase II Trial on Lung Malignancies: The ALICE Trial" by Ricke et al. 2015 (doi:10.1007/s00270-014-1049-0). Cardiovasc Intervent Radiol. 2015 Aug;38(4):1064-5. doi: 10.1007/s00270-015-1096-1. Epub 2015 Apr 23. No abstract available.
PubMed 25902855
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Monocentric, Clinical Phase-I/II Study of the Effectiveness of the Percutaneous Irreversible Electroporation (IRE) of Locally Confined Kidney Tumors (Renal Cell Carcinomas).
- ClinicalTrials.gov ID
- NCT01967407
- Acronym / sponsor ID
- IRENE / DE-UKMD-URO-001
- Conditions
- Kidney Tumor, Renal Cell Cancer
- Keywords
- kidney tumor, renal cell cancer, RCC, irreversible electroporation, IRE, partial kidney resection, percutaneous, ablation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of MagdeburgUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 22 Oct 2013 (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 aim of the study is the evaluation of the ablation efficiency of the percutaneous irreversible electroporation (IRE) as primary ablation therapy of locally confined renal cell carcinoma (≤4cm, see inclusion and exclusion criteria).
The ablation success will be proofed by magnet resonance imaging (MRI) and histologically after partial kidney resection or nephrectomy 4 weeks after IRE. Hypotheses: Kidney tumors ≤4cm can be ablated completely by percutaneous IRE. Surrounded structures and renal tissue can be preserved.
Detailed description
Health Condition or Problem studied:
- International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD10): C64 - Malignant neoplasm of kidney, except renal pelvis
- ICD10: D41.0 - Neoplasm of uncertain or unknown behaviour: Kidney
Interventions/Observational Groups Arm 1:
- Initial diagnostical examination of the renal mass.
- If any extended diagnostical examination for treatment planning.
- Day -29 to -1: Recruitment.
- Day -1: MRI of the kidney, Karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment.
- Day 0: Percutaneous diagnostical biopsy with histopathological investigation and therapeutically, CT- and/or ultrasound-guided, ECG-synchronized irreversible electroporation (IRE) of the kidney tumor in endotracheal anaesthesia und muscle relaxation. Use of 1-6 IRE probes with 90-100 pulses of 1500-3000 volts und 20-50 amperes each.
- Day 1-7: Postinterventional follow-up: MRI of the kidneys, Karnofsky, physical examination, blood chemistry, urosonography, life quality assessment.
- Day 27: Postinterventional follow-up: MRI of the kidneys, Karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment.
- Day 28: Open surgery partial kidney resection or tumor nephrectomy of the IRE treated kidney resp. kidney tumor region with histopathological investigation.
- Day 29-37: Postoperative follow-up: physical examination, blood chemistry, urosonography, life quality assessment.
- Day 112: Study-Follow-up: MRI of the kidneys, Karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment. Termination of the study.
- Study closed, Individual follow-up due to the European Association of Urology guideline.
Recruitment:
- (Anticipated or Actual) Date of First Enrollment: 2013/10/14
- Planned/Actual: Opened
- Target Sample Size: 20
- Monocentric/Multicentric trial: Monocentric trial
- National/International: National
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| renal tumor <4cm, suspected RCC | Experimental | Procedure: Irreversible Electroporation (IRE)Intervention/ Time point: Irreversible Electroporation at day 0 of each patient. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- one or more localized, resectable kidney tumors (≤4 cm) suspicious of malignancy or histology -proven renal cell cancer (RCC)
- patients desire for therapy and surgical therapy
- Karnofsky-index >70%
- Age ≥ 18 years
- life expectancy ≥ 12 month
Key exclusion criteria (25 listed)
- violation against one or more inclusion criteria
- cardial pacemaker or other electrical implants
- QT-interval >550 ms or cardiac arrhythmias or condition after myocardial infarction, that make an ECG-synchronisation unfeasible
- known cardial ejection fraction < 30% or NYHA III or III-IV
- known epilepsy
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 Electroporation (IRE)Also: NanoKnife (Tissue Ablation) System, AngioDynamics Inc.Percutaneous CT-fluoroscopic-guided Irreversible Electroporation. | Procedure or surgery | renal tumor <4cm, suspected RCC |
Primary outcome
analysis of ablation effectiveness of non-metastatic renal tumors <4cm 28 days by after irreversible electroporation (NanoKnife, AngioDynamics Inc.) by histopathological examination of partial kidney resection specimens
Time frame: 28 days
onco-therapeutic effectiveness, measured against persistent active tumor / cancer cells by histopathological and magnet resonance imaging analysis
1 secondary outcome
safety
Time frame: 4 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
- Background: PubMed 23139026Liehr UB, Wendler JJ, Blaschke S, Porsch M, Janitzky A, Baumunk D, Pech M, Fischbach F, Schindele D, Grube C, Ricke J, Schostak M. [Irreversible electroporation: the new generation of local ablation techniques for renal cell carcinoma]. Urologe A. 2012 Dec;51(12):1728-34. doi: 10.1007/s00120-012-3038-8. German.
- Background: PubMed 25389236Jiang C, Davalos RV, Bischof JC. A review of basic to clinical studies of irreversible electroporation therapy. IEEE Trans Biomed Eng. 2015 Jan;62(1):4-20. doi: 10.1109/TBME.2014.2367543.
- Derived from this study: PubMed 25902855Wendler JJ, Porsch M, Fischbach F, Pech M, Schostak M, Liehr UB. Letter to the Editor Concerning "Irreversible Electroporation (IRE) Fails to Demonstrate Efficacy in a Prospective Multicenter Phase II Trial on Lung Malignancies: The ALICE Trial" by Ricke et al. 2015 (doi:10.1007/s00270-014-1049-0). Cardiovasc Intervent Radiol. 2015 Aug;38(4):1064-5. doi: 10.1007/s00270-015-1096-1. Epub 2015 Apr 23. No abstract available.
- Department of Urology, University MagdeburgLink provided by the sponsor.
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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.
Uwe- B. Liehr, Dr. med. principal investigator
Department of Urology, University Magdeburg, Germany.
Martin Schostak, Prof. Dr. study director
Department of Urology, University Magdeburg, Germany
Johann J. Wendler, Dr. med. principal investigator
Department of Urology, University Magdeburg, Germany
4 sites 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 Irreversible Electroporation (IRE) in people with Kidney Tumor and Renal Cell Cancer, run by University of Magdeburg at 4 sites in Germany.
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 25 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 19 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 4 sites in Germany. 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 Antje Wiede, Dr. (+493916721841, antje.wiede@med.ovgu.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
analysis of ablation effectiveness of non-metastatic renal tumors <4cm 28 days by after irreversible electroporation (NanoKnife, AngioDynamics Inc.) by histopathological examination of partial kidney resection specimens (time frame: 28 days). 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 NCT01967407, which also lists 3 linked publications.
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 19 Nov 2014.