IReversible Electroporation of Kidney Tumors Before Partial Nephrectomy. (IRENE)

University of Magdeburg

Status and phase: Unknown; Phase 2; Phase 1

Conditions: Kidney Tumor; Renal Cell Cancer

Treatments: Procedure: Irreversible Electroporation (IRE)

Study type: Interventional

Funder types: Other

Identifiers

NCT01967407

EUDAMED-No.: CIV-12-04-006021 (Other Identifier)

00020520 (Other Identifier)

DE-UKMD-URO-001

DRKS00004266 (Other Identifier)

U1111-1140-0415 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Exclusion criteria

• 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)
• 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 design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

renal tumor <4cm, suspected RCC

Experimental group

Description:

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

Treatment:

Procedure: Irreversible Electroporation (IRE)