IReversible Electroporation of Kidney Tumors Before Partial Nephrectomy.

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

PHASE1/PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2016-01-31

Brief Summary

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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

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Health Condition or Problem studied:

1. International Statistical Classification of Diseases and Related Health Problems, Tenth Revision (ICD10): C64 - Malignant neoplasm of kidney, except renal pelvis
2. ICD10: D41.0 - Neoplasm of uncertain or unknown behaviour: Kidney

Interventions/Observational Groups Arm 1:

1. Initial diagnostical examination of the renal mass.
2. If any extended diagnostical examination for treatment planning.
3. Day -29 to -1: Recruitment.
4. Day -1: MRI of the kidney, Karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment.
5. 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.
6. Day 1-7: Postinterventional follow-up: MRI of the kidneys, Karnofsky, physical examination, blood chemistry, urosonography, life quality assessment.
7. Day 27: Postinterventional follow-up: MRI of the kidneys, Karnofsky, physical examination, blood chemistry, urosonography, if any renal scintigraphy, life quality assessment.
8. Day 28: Open surgery partial kidney resection or tumor nephrectomy of the IRE treated kidney resp. kidney tumor region with histopathological investigation.
9. Day 29-37: Postoperative follow-up: physical examination, blood chemistry, urosonography, life quality assessment.
10. 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.
11. 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

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Kidney Tumor Renal Cell Cancer

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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renal tumor <4cm, suspected RCC

Intervention/ Time point: Irreversible Electroporation at day 0 of each patient.

Group Type EXPERIMENTAL

Irreversible Electroporation (IRE)

Intervention Type PROCEDURE

Percutaneous CT-fluoroscopic-guided Irreversible Electroporation.

Interventions

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Irreversible Electroporation (IRE)

Percutaneous CT-fluoroscopic-guided Irreversible Electroporation.

Intervention Type PROCEDURE

Other Intervention Names

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NanoKnife (Tissue Ablation) System, AngioDynamics Inc.

Eligibility Criteria

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Inclusion Criteria

* 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

* 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)
* 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Johann J. Wendler, MD

Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Uwe- B. Liehr, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, University Magdeburg, Germany.

Martin Schostak, Prof. Dr.

Role: STUDY_DIRECTOR

Department of Urology, University Magdeburg, Germany

Johann J. Wendler, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Department of Urology, University Magdeburg, Germany

Locations

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Department of Pathology University Hospital Otto-von-Guericke-University Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Site Status RECRUITING

Department of Radiology University Hospital Otto-von-Guericke-University Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Site Status RECRUITING

Department of Urology University Hospital Otto-von-Guericke-University Magdeburg

Magdeburg, Saxony-Anhalt, Germany

Site Status RECRUITING

MVZ Hanse Histologikum GmbH Hamburg

Hamburg, , Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Antje Wiede, Dr.

Role: CONTACT

[email protected]

+493916721841

Johann J. Wendler, Dr. med.

Role: CONTACT

[email protected]

+493916715036

Facility Contacts

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Jens Köllermann, PD Dr. med.

Role: primary

[email protected]

0049-40-707085200

References

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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.

Reference Type BACKGROUND

PMID: 23139026 (View on PubMed)

Jiang 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.

Reference Type BACKGROUND

PMID: 25389236 (View on PubMed)

Wendler 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.

Reference Type DERIVED

PMID: 25902855 (View on PubMed)