Irreversible Electroporation(IRE) For Unresectable Renal Tumors

Renal Tumor Clinical Trial

— IRE  

Official title:

Irreversible Electroporation (IRE) for Unresectable Renal Tumors: Phase I and Phase II Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02335827
• Other study ID #: IRE-001
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: January 1, 2021

Study information

• Verified date: June 2020
• Source: Fuda Cancer Hospital, Guangzhou
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to investigate the safety and efficacy of irreversible electroporation (IRE) for unresectable renal tumors.

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 .

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: January 1, 2021
• Est. primary completion date: May 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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.

Related Conditions & MeSH terms

• Kidney Neoplasms
• Renal Tumor

Intervention

Procedure:
• irreversible electroporation
Percutaneous (CT-guided and/or US-guided) or open IRE with voltage in level B for renal tumors

Locations

Country	Name	City	State
China	Fuda Cancer Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Fuda Cancer Hospital, Guangzhou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Progress free disease (PFS)	Patients will be followed for 12 months after IRE for PFS assessing.	12 months
Other	Overall survival (OS)	Patients will be followed for 36 months after IRE for OS analyzed.	36 months
Primary	adverse effects	adverse effects measured by such as abdominal bleeding, continuous abdominal pain, renal failure, et al.	1 month
Primary	Quality of Life (QoL)	Quality of Life assessed as WHOQOL-BREF.	2 months
Primary	procedural compliance	compliance will be analyzed by 3 months of follow-up post procedure.	3 months
Secondary	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.	12 months
Secondary	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.	3 months