Neoplasms

Symptoms and General Pathology

All Conditions

Digestive System Diseases

Neoplasm Metastasis

Liver Diseases

Liver Neoplasms

Neoplastic Processes

Gastrointestinal Diseases

Gastrointestinal Neoplasms

Digestive System Neoplasms

Hematinics

All Drugs and Chemicals

Liver Extracts

Single arm study: Irreversible electroporation of colorectal liver metastasis

Tumor ablation with irreversible electroporation with the NanoKnife

Irreversible electroporation (IRE)

Martijn R Meijerink, MD, PhD

Petrousjka M van den Tol, MD, PhD

C van Kuijk, Prof. Dr.

Irreversible electroporation is a new, minimal-invasive image-guided treatment to treat tumors near or around vulnerable structures, such as central liver tumors.

To investigate the safety and efficacy of IRE in the treatment of colorectal liver metastases, patients with resectable colorectal liver metastases undergo IRE and resection of the metastases in the same session. After resection, the specimen is examined macroscopically to determine vitality using a specific vitality staining (triphenyl-tetrazoliumchloride) and to visualize the exact ablation zone. Subsequently, histopathologic examination is used to determine type of cell death and the microscopic ablation zone.

The investigators hypothesize that IRE is a safe effective method to treat colorectal liver metastasis and that cell damage and cell death is demonstrated as soon as 1 hour after the procedure.

This pilot-study is designed to determine the safety of IRE using the NanoKnife on colorectal liver metastases. Secondary, feasibility, histological effect on the ablated cells and exact shape and size of the ablated area will be determined.

Study design:

Patients with resectable CRLM (1 lesion or more) undergoing surgical resection of the metastases will receive study information to participate in this pilot-study. Limited extrahepatic disease is not contra-indicated.

Patients will undergo a general pre-procedural work-up: total body FDG PET-CT, ceCT of the abdomen, anesthetic review with special attention to cardiac history, baseline full blood examination, urea and electrolytes, renal function tests, liver enzymes and coagulation profile test.

The procedure is conducted under general anaesthesia with muscle relaxants to prevent patient motion and epidural analgesia. A laparotomy will be performed at the surgeon's discretion for optimal liver exposure. Intraoperative ultrasonography (IOUS) will be carried out by an experienced interventional radiologist for exact evaluation of maximum diameter, number and location of all lesions and to confirm resectability (if lesions prove not to be resectable, only RFA will be performed according to standard of care). All lesions will be biopsied. The electrodes will be placed under ultrasound guidance according to manufacturer's guidelines in the lesions that are eligible for resection. After correct placement of the electrodes the lesions will be ablated according to protocol with ECG synchronization and the ablation zone is determined by US.

During the procedure the cardiac rhythm will be closely monitored and a defibrillator will be present at all times.

After IOUS confirmation of complete ablation (at least 30 minutes after ablation of the lesion) the surgeon will perform a partial liver resection / metastasectomy including the ablated lesions and the surgical procedure is ended as usual. After the treatment of all lesions with the NanoKnife and before resection (and RFA of unresectable CRLM if indicated), blood samples will be drawn to determine renal function and liver enzymes since cell destruction may cause biochemical abnormalities.

The resected specimen will be transported to the department of pathology. After sectioning, the specimen will be photographed extensively to determine exact shape and size of the ablated area. One slice is stained in vitality-staining (TTC), to macroscopically distinguish viable from nonviable tissue.

After formalin fixation, the specimen is stained and examined under light microscopy according to standard protocol to determine radicality of the resection margins. Additionally, special attention will be given to indications for cellular damage, vessel wall damage and size and shape of the ablation zone. Caspase-3 and BAX/BCL-2 analysis will be performed to investigate the induction of apoptosis. The results will be compared to the result of the biopsy taken prior to ablation.

On day one and day three post-operatively regular blood samples will be drawn, including liver enzymes and renal function tests. After discharge, out of hospital follow-up will be according to liver surgery protocol. The investigators aim to include 10 patients in this pilot study.

Monitoring:

An independent monitor (quality officer) will monitor all study data according to Good Clinical Practice (GCP). The informed consent of selected individual participants will be checked. Source Data verification will be performed during onsite monitoring (to verify if all data on the Case Report Form are in accordance with the source data). The intensity of this verification is in relation to the risk associated with the intervention investigated. Data that by all means will be checked are the informed consent form, in- and exclusion criteria and the primary outcome. The monitor will also verify if all (S)AE's and SUSAR's are reported adequately and within the time that is determined by legal rules and regulations.

Prospective ablate and resect trial where 10 patients with resecatble colorectal liver metastases were treated with irrevrsible electroporation approximately 2 hours before the tumors were resected.

Pilot-study: Non-thermal Ablation Using Irreversible Electroporation to Treat Colorectal Liver Metastases

Pilot-study: Non-thermal Ablation Using Irreversible Electroporation (IRE) to Treat Colorectal Liver Metastases - "Ablate and Resect"

The investigators hypothesize that it will initially take several replacements before adequate positioning is obtained. It is suspected that placement of the electrodes will become easier in the course of the study and that procedure time will decrease (expressed in learning curve).

Safety using Common terminology Criteria for Adverse Events (CTCAE). Since the ablated tissue will be resected we expect procedure-related complications to occur mainly during the procedure.

Cell death of CRLM after IRE is demonstrated macroscopically by using vitality-staining with triphenyl-tetrazoliumchloride (TTC). Since and shape of the ablation zone is assessed. Immunohistologic examination is used to more specifically assess microscopic cell damage and vessel wall damage. Apoptotic markers are used.

Amsterdam UMC, location VUmc

Dr. M.R. Meijerink

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

Gastrointestinal Agents

Anesthetics

Diuretics

Pancrelipase

Pancreatin

Men randomized to the experimental arms will be offered focal treatment of prostate cancer with IRE technology. IRE stands for "irreversible electroporation" and involves the use of high voltage electrical pulses to treat solid tumors by increasing membrane permeability and inducing membrane disruption, leading to cell death.

Men eligible for radical prostatectomy and randomized to the control arm will undergo radical prostatectomy in line with national guidelines.

Men eligible for radiation therapy and randomized to the control arm will undergo radiation therapy in line with national guidelines.

IRE involves the use of high voltage electrical pulses to treat solid tumors by increasing membrane permeability and inducing membrane disruption, leading to cell death. The technique is used in Sweden today in radical ablative therapies in the treatment of tumors in the liver, kidney and pancreas. Prior to treatment a Foley catheter is placed. During the treatment, which takes place under anesthesia, the patient is placed in gynecological position and the tumour lesion is located with BK transrectal fusion ultrasound. Thereafter the needles are placed transperineal around the tumor in the prostate using a brachytherapy grid (17Ga Civco brachytherapy grid), guided by the ultrasound/MRI fusion images. Through the needles electrical pulses are then sent to treat the tumor in the center using the Nanoknife technique. After treatment patients are treated with diuretics to flush the kidneys post treatment.

Irreversible electroporation, IRE

Radical prostatectomy

Radiation therapy

Anna Lantz, Ass Prof

Olof Akre, Prof

Anna Lantz, MD PhD

The aim of this study is to evaluate the feasibility to treat localized prostate cancer diagnosed with MRI and targeted/systematic biopsies, with IRE in comparison with conventional radical treatments with the primary objective to locally control the tumour with a minimum of side effects.

OBJECTIVES The aim of the proposed research is to evaluate the cancer control, genitourinary, rectal and overall health-related quality of life outcomes of focal therapy for unifocal localized prostate cancer using irreversible electroporation (IRE).

PRIMARY AIM

• To evaluate functional outcomes in men treated for unifocal ISUP 2-3 localized prostate cancer with focal treatment in comparison to conventional treatment with either radical prostatectomy or radiation therapy

SECONDARY AIMS

* To evaluate adverse events in men treated for unilfocal ISUP 2-3 localized prostate cancer with focal treatment in comparison to conventional treatment with either radical prostatectomy or radiation therapy
* To evaluate progression free and treatment free survival in men treated for unifocal ISUP 2-3 localized prostate cancer with focal treatment in comparison to conventional treatment with either radical prostatectomy or radiation therapy
* Economic evaluation of each technique

TRIAL DESIGN This study is a randomized controlled exploratory trial comparing focal therapy to conventional radical treatment of prostate cancer with the primary aim to evaluate functional outcomes 12 months after treatment.

Patients will be included from 4 different hospitals within the Stockholm County; Karolinska University Hospital, Danderyd Hospital, St Görans Hospital, Södersjukhuset. Eligible patients, after MRI and targeted/systematic biopsies, will be men with clinically significant intermediate-risk PCa or dominant unifocal clinically significant intermediate-risk and small contralateral low-risk disease without previous history of prostate cancer treatment.

Potential study participants will have a visit scheduled together with an urologist and oncologist, where a treatment decision of radical prostatectomy or radiation therapy will be done together with the patient. At this visit the patient will receive oral and written information about the study. If the patient is interested in participating, a baseline visit is scheduled during which informed consent is obtained and the patient randomized to one of two standard treatments or focal treatment.

Patients eligible for radical prostatectomy will be randomized in study 1 to focal treatment or radical prostatectomy. Patients eligible for radiation therapy will be randomized in study 2 to focal treatment or radiation therapy. Time between randomization and treatment will be \<= 6 weeks.

Patients will be asked to fill out study specific questionnaires with questions on functional outcomes and quality of life.

Main outcome measurement in study 1 will be urinary incontinence at 12 months post treatment and in study 2 irritative urinary symptoms 12 months post treatment. Further outcomes will be erectile dysfunction, adverse events, progression-free and treatment-free survival.

Prostate Cancer IRE Study (PRIS)

Prostate Cancer IRE Study (PRIS) - A Randomized Controlled Trial Comparing Focal to Radical Treatment in Localized Prostate Cancer

Urinary incontinence defined by Q3 in EPIC-26, ≥1 pad/day ("Yes") versus none ("No")

Irritative urinary symptoms defined by Q4e in EPIC-26, Moderate/big problem ("Yes") Versus no/small problem ("No")

IIEF score: International Index of Erectile Function, change. The possible scores for the IIEF-5 range from 5 to 25, and ED was classified into five categories based on the scores: severe (5-7), moderate (8-11), mild to moderate (12-16), mild (17-21), and no ED (22-25).

International Prostate Symptom Score (IPSS score), change. It is a validated, reproducible scoring system to assess disease severity and response to therapy. The IPSS is made up of 7 questions related to voiding symptoms. A score of 0 to 7 indicates mild symptoms, 8 to 19 indicates moderate symptoms and 20 to 35 indicates severe symptoms.

Expanded Prostate Cancer Index, EPIC-26, Q6 change in score. The EPIC-26 is a validated instrument that measures health-related quality of life across 5 PCa-specific domains. Consequently, the minimum symptom score (best HRQOL) = 0 and the maximum symptom score (worst HRQOL) = 12 in each domain. For consistency, the values assigned to each question range from 0 (best) to 4 (worst) regardless of whether there were 4 or 5 response options per question.

EQ5D; The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.

1. Need for additional focal or whole gland treatment or ADT
2. Need for whole gland treatment or ADT
3. Need for whole gland treatment or ADT or ISUP 2 at 12 mo biopsy

Post-operative PSA ≥0.2 ng/ml or adjuvant treatments including ADT

PSA \>2 over nadir (Phoenix) or adjuvant treatments including ADT

Karolinska University Hospital

Karolinska Institutet

MD PhD Principal Investigator Associate Professor

Rare Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Carcinoma

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Renal Cell Carcinoma

Analgesics

Morphine

Percutaneous, CT guided, Irreversible Electroporation of renal mass

Percutaneous, CT guided, ablation of renal mass

Nano Knife

Prof. M. Pilar Laguna Pes, M.D. Ph.D.

Peter GK Wagstaff, M.D.

Prof. Jean J de la Rosette, M.D. Ph.D.

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.

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.

Efficacy and Safety of IRE for RMs

The Efficacy and Safety of Irreversible Electroporation for the Ablation of Renal Masses: A Prospective, Human, In-Vivo Study.

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.

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

M.D.

Gland and Hormone Related Diseases

Pancreatic Neoplasms

Endocrine Gland Neoplasms

Pancreatic Diseases

Endocrine System Diseases

Pancreatic Cancer

Single arm study: Percutaneous irreversible electroporation of locally advanced pancreatic carcinoma

NanoKnife "Irreversible electroporation (IRE)"

Geert Kazemier, Prof. Dr.

Cornelis van Kuijk, Prof. Dr.

Irreversible electroporation (IRE) is a new, minimal-invasive image-guided treatment method for tumors not amenable for surgical resection or thermal ablation, due to vicinity near vital structures such as vessels and bile ducts. With IRE, multiple electrical pulses are applied to tumorous tissue. These pulses alter the existing transmembrane potential of the cell membranes, and create 'nanopores', after which the cell dies through loss of homeostasis.

The purpose of this study is to investigate the safety of percutaneous IRE in the treatment of patients with locally advanced pancreatic carcinoma (LAPC). Other objectives are feasibility and efficacy of IRE based upon symptomatic response and tumor response.

Fourty patients with histologically confirmed locally advanced pancreatic adenocarcinoma (\<5cm) will undergo percutaneous irreversible electroporation of the tumor using CT and ultrasound guidance. After IRE, patients will be carefully monitored and any (serious) adverse events are registered. Follow-up will consist of frequent CT scanning, as well as serum CA19.9 tumor marker.

We hypothesize that IRE in the pancreas will induce good symptom palliation and local tumor control, without causing severe complications.

PANFIRE Study: Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma

PANFIRE - Pilot-study: Non-thermal Ablation Using Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma - a Phase I Clinical Trial

Number of adverse events of IRE-treatment (within 12 months after treatment) are registered and analyzed according to the CTCAE version 4.0. Complications related to IRE are early complications during hospital admission (e.g. bile leak, bowel leak, infection, pancreatitis), or late complications of IRE such as bile duct stenosis that become apparent during follow-up in the year after treatment.

* Ablation success: the ability to deliver the planned therapy and at 3 months to have no evidence of residual tumor;
* Local recurrence rate (LRR): defined as the reappearance of viable tumor after a period of time during which viable tumor could not be detected;
* Overall survival and (local and distant) progression-free survival.

Applying the steep pulse to treat the patients with Prostate cancer

Steep Pulse Device

This trial is studying the effects and safety in treating patients from five different centers with local prostate cancer, employing Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus. This device could cause cell irreversible electroporation, which leading necrosis of tumor cells. It also has the ability to prevent nerve,vessel, urethral and capsule unnecessary injury beside the ablation area. Composite Steep-pulse Treatment Apparatus will be used in patients who pass inclusion/exclusion criteria. Safety, quality of life, and histopathological analysis of prostate speciem will be evaluated in each study patients.

Background:

Prostate cancer is the most common cancer in elderly males in western country. It is also a major health concern, especially in China with its greater proportion of elderly men in the general population. Currently, radical prostatectomy(RP) is the mainstream treatment for localized PCa to show a benefit for cancer-specific survival (CSS). However, the patient who underwent RP might suffer from the complication of erectile dysfunction or urinary incontinence. In 2004, a new method using steep pulses to treat tumor was appeared. It showed that steep pulses could bring about Irreversible Electroporation (IRE) of cell, leading tonecrosis of tumor cells. And it seemed to do no harms to the nerve and Vascular epithelial cell. The device of steep pulse had already been approved by FDA in 2011.However, this device of steep pulse has disadvantages like: (1)sever muscle contraction;(2)Urethral injury; (3)Capsule injury;(4)Nerve degeneration. This new device which is called Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus, may have the potential to conquer these disadvantages.

Purpose:

1. This study will assess the efficacy of Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus in the treatment of PCa.
2. This study will assess the safety of Composite Steep-pulse(High-frequency irreversible electroporation) Treatment Apparatus in the treatment of PCa.

Methods:

1. patients recruitment
2. transperineal maping prostate biopsy(\>20 needle) guided by transrectal ultrasound(TRUS).
3. Irreversible Electroporation of malignant Tumor Cell under Composite Steep-pulse Treatment for the patients with positive biopsy;
4. Some factors such as prostate MRI,the maping prostate biopsy(\>20 needle),the histopathological outcomes analysis ect. will be performed to evaluate the efficacy of the treatment.
5. Other factors such as the routine blood test, the routine urine test, the urinary continence ect. will be performed to evaluate the safety of the treatment.

The Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Ablation Therapy

The Efficacy and Safety of Composite Steep-pulse(High-frequency Irreversible Electroporation) Treatment Apparatus Used in Prostate Cancer Ablation Therapy : a Multicenter, Single-arm, Objective Performance Criteria Trial

evaluation of pathological analysis from the biopsy sample to confirm if there remain clinically significant prostate cancer

evaluation of ablation range from prostate MRI to confirm if there remain suspicious lesions

evaluation of urination function by IPSS scoring

evaluation of sexual function by IIEF-5 scoring

Record of urinary catheter retention time

RenJi Hospital

Peking Union Medical College Hospital

Zhejiang University

Second Military Medical University

director, head of uroglogy department, clinical professor

Clear Cell Renal Cell Carcinoma

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

Percutaneous CT-fluoroscopic-guided Irreversible Electroporation.

Irreversible Electroporation (IRE)

Antje Wiede, Dr.

Johann J. Wendler, Dr. med.

Sandra Böttcher, Dr.

Albert Roessner, Prof.

Jens Ricke, Prof.

Frank Fischbach, Prof.

Maciej Pech, Prof.

Julian Jürgens

Markus Porsch, Dr.

Andreas Janitzky, Dr.

Daniel Baumunk, Dr.

Daniel Schindele, Dr.

Simon Blaschke

Jens Köllermann, PD Dr. med.

Jens Köllermann, PD Dr. med

Uwe- B. Liehr, Dr. med.

Martin Schostak, Prof. Dr.

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.

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

IReversible Electroporation of Kidney Tumors Before Partial Nephrectomy.

Prospective, Monocentric, Clinical Phase-I/II Study of the Effectiveness of the Percutaneous Irreversible Electroporation (IRE) of Locally Confined Kidney Tumors (Renal Cell Carcinomas).

onco-therapeutic effectiveness, measured against persistent active tumor / cancer cells by histopathological and magnet resonance imaging analysis

* adverse effects
* Assessment of the procedural compliance
* Assessment of the Quality of Life (QoL)

University of Magdeburg

Dr. med.

Cholangiocarcinoma

Carcinoma, Hepatocellular

Bile Duct Neoplasms

Biliary Tract Neoplasms

Bile Duct Diseases

Biliary Tract Diseases

Bile Duct Cancer

Primary Liver Cancer

Selected patients who choose to participate will undergo ablation of the target lesion using irreversible electroporation.

The IRE procedure will be carried out as ultrasound guided technique either percutaneously or during laparotomy. Needle spacing and electrical pulse delivery will be performed in a standardized way.

Irreversible electroporation

Ole Thorlacius-Ussing, Professor, DMSc

The aim of this study is to evaluate the safety and feasibility of curative intended irreversible electroporation (IRE) in the treatment of liver tumors neighboring major vessels or bile ducts.

Patients can be included in the study if they have one or more malignant liver tumors unsuitable for resection and thermal ablation (due to proximity of major vessels or bile duct) or other established liver directed therapies.

Prior to inclusion all potential participant will be evaluated by the local multidisciplinary team, to insure fulfillment of the above-mentioned criteria. In general, the included patient will have tumors with \<1 cm of margin to major hepatic vessels or bile ducts, thereby not allowing for conventional treatments because of risk of i.e. hemorrhage, biliary tract damage, liver failure or ineffective ablation due to heat sink.

IRE will be done under general anesthesia as an in-patient procedure. Patients will be observed for at least 24 hours after IRE.

Patients will attend CT scans 1, 3, 6, 9, 12, 18, 24, 36, 48 and 60 months post-IRE according to national guidelines (for follow-up after radiofrequency ablation (RFA)). Patients will attend the out-patient clinic after 1, 3, 6, 9, 12, 18 and 24 months. During the follow-up period, patients will be asked to fill out electronic forms monitoring pain, quality of life and nutritional status. After 24 months the patients will only be followed with CT scans in accordance with the mentioned schedule. Data collection for scientific purposes will stop when the last included patient has been followed for at least 24 months or when the study period concludes.

In case of multiple liver tumors, where a conventional treatment approach is not possible due to a single lesion being too close to major vessels or bile ducts, IRE may be used in conjunction to conventional therapy.

Irreversible Electroporation of Unresectable Liver Tumors

Irreversible Electroporation of Unresectable Liver Tumors - a Phase I Study of Safety and Feasibility

Adverse events will be registered and scaled according to the Clavien-Dindo classification.

The rate of patients were it is possible to place needles according to the treatment plan and deliver 90 electrical pulses per electrode pair

The rate of patients showing no residual tumor on contrast enhanced computed tomography (ceCT)

The median time from the intervention to progressive disease of the treated lesion, according to RECIST 1.1 or modified RECIST (mRECIST) (only for HCC).

The median time from the intervention to death.

Quality of life questionnaire - Core 30 is used to assess the quality of life in the included patients. Raw scores will be calculated according to the manual. Items will be grouped in: Global health status (range 0 - 100, high is good), Functional scales (range 0 - 100, high is good) and symptom scales (range 0 - 100 low is good). Differences in each scales during the course of the trial will be calculated separately.

Long term pain will be assessed using the modified Danish version of the Brief Pain Inventory - short form. The outcomes assessed will be an average score of pain severity items and interference items in accordance with the manual. The scales range from 0 to 10 (lower is less pain).

Perioperative pain will be scores using the visual analogue pain scale (range 0 - 10, low score is less pain).

Physicians assessment of global functioning using the "Eastern Cooperative Oncology Group" performance status scale (range 0 - 5, low score is better)

Nutritional status assessment using the Scored Patient-Generated Subjective Global Assessment (short form). The short form includes only patient reported measures and will be combined into a single score according to the manual (range 0 - 37, low score is better).

Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery

Professor of surgery, Consultant surgeon, DMSc

steep pulse device

yinghao sun, MD,PHD

This trial is studying the effects and safety in treating patients with local prostate cancer with a new IRE device called Composite Steep-pulse Treatment Apparatus. This new device could cause cell irreversible electroporation, which leading necrosis of tumor cells. It also has the ability to prevent nerve,vessel, urethral and capsule unnecessary injury beside the ablation area. Composite Steep-pulse Treatment Apparatus will be used in patients who pass inclusion/exclusion criteria. Safety, quality of life, and histopathological analysis of prostate speciem will be evaluated in each study patients.

Background:

Prostate cancer is the most common cancer in elderly males in western country. It is also a major health concern, especially in China with its greater proportion of elderly men in the general population. Currently, radical prostatectomy(RP) is the mainstream treatment for localized PCa to show a benefit for cancer-specific survival (CSS). However, the patient who underwent RP might suffer from the complication of erectile dysfunction or urinary incontinence. In 2004, a new method using steep pulses to treat tumor was appeared. It showed that steep pulses could bring about Irreversible Electroporation (IRE) of cell, leading tonecrosis of tumor cells. And it seemed to do no harms to the nerve and Vascular epithelial cell. The device of steep pulse had already been approved by FDA in 2011.However, this device of steep pulse has disadvantages like: (1)sever muscle contraction;(2)Urethral injury; (3)Capsule injury;(4)Nerve degeneration. This new device which is called Composite Steep-pulse Treatment Apparatus, may have the potential to conquer these disadvantages.

Purpose:

1. This study will assess the efficacy of Composite Steep-pulse Treatment Apparatus in the treatment of PCa.
2. This study will assess potency, urinary continence and complication rate for the patients undergo the treatment with steep pulse device.
3. Histopathological analysis of prostate speciem 4 weeks after treated by Composite Steep-pulse Treatment Apparatus.

Methods:

1. patients recruitment
2. transperineal prostate targeted biopsy guided by multiparametric magnetic resonance imaging/transrectal ultrasound (mpMRI/TRUS) fusion, plus systemic prostate biopsy.
3. Frozen pathological analysis will be performed;
4. Irreversible Electroporation of malignant Tumor Cell under Composite Steep-pulse Treatment for the patients with positive biopsy;
5. Complication, urinary continence, and sexual function will be evaluated after the IRE treatment;
6. RP for these patients in 4 weeks after the treatment of Composite Steep-pulse Treatment.
7. Histopathological Outcomes analysis will be performed to evaluate tumor residual rate, urethral injuries, nerve injuries and capsule injury in and beside the ablation area.

The Efficacy and Safety of Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Focal Therapy

The Efficacy and Safety of Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Focal therapy-a Phase I Study

To determine if the IRE(with Composite Steep-pulse Treatment Apparatus) ablation procedure is safe as measured by the composite number of procedural, device and post procedural adverse events measured with the CTCAE proforma.

Persentage of normal glandular tissue in the specified targeted ablation zone by histopathology assessment

Mean sexual function domain score (IIEF-5 scoring:

The IIEF-5 score is the sum of the ordinal responses to the 5 items. 22-25: No erectile dysfunction 17-21: Mild erectile dysfunction 12-16: Mild to moderate erectile dysfunction 8-11: Moderate erectile dysfunction 5-7: Severe erectile dysfunction)

Mean urinary incontinence domain score (the number of pad everyday,good is less than 2 pads a day, more or equal than 2 pads a day)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Pilot-study: Non-thermal Ablation Using Irreversible Electroporation to Treat Colorectal Liver Metastases	NCT01799044	Colorectal Live... Metastatic Live...	Irreversible el...	18 Years -	Amsterdam UMC, location VUmc
Prostate Cancer IRE Study (PRIS)	NCT05513443	Prostate Cancer	Irreversible el... Radical prostat... Radiation thera...	40 Years -	Karolinska Institutet
Efficacy and Safety of IRE for RMs	NCT02298608	Kidney Cancer	Nano Knife	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
PANFIRE Study: Irreversible Electroporation (IRE) to Treat Locally Advanced Pancreatic Carcinoma	NCT01939665	Locally Advance... Non-metastasize... Pancreatic Canc...	NanoKnife "Irre...	18 Years -	Amsterdam UMC, location VUmc
The Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Ablation Therapy	NCT03838432	Prostate Cancer	Steep Pulse Dev...	40 Years - 85 Years	Second Military Medical University
Pilot-study: Non-thermal Ablation Using Irreversible Electroporation to Treat Colorectal Liver Metastases	NCT01799044	Colorectal Live... Metastatic Live...	Irreversible el...	18 Years -	Amsterdam UMC, location VUmc
IReversible Electroporation of Kidney Tumors Before Partial Nephrectomy.	NCT01967407	Kidney Tumor Renal Cell Canc...	Irreversible El...	18 Years -	University of Magdeburg
Prostate Cancer IRE Study (PRIS)	NCT05513443	Prostate Cancer	Irreversible el... Radical prostat... Radiation thera...	40 Years -	Karolinska Institutet
Irreversible Electroporation of Unresectable Liver Tumors	NCT04404647	Liver Metastase... Hepatocellular ... Bile Duct Cance...	Irreversible el...	18 Years -	Aalborg University Hospital
Pilot-study: Non-thermal Ablation Using Irreversible Electroporation to Treat Colorectal Liver Metastases	NCT01799044	Colorectal Live... Metastatic Live...	Irreversible el...	18 Years -	Amsterdam UMC, location VUmc
Efficacy and Safety of IRE for RMs	NCT02298608	Kidney Cancer	Nano Knife	18 Years -	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
The Efficacy and Safety of Composite Steep-pulse Treatment Apparatus Used in Prostate Cancer Focal Therapy	NCT03315585	Prostate Cancer	steep pulse dev...	30 Years - 75 Years	Second Military Medical University

Spots Global Cancer Trial Database for ire

Every month we try and update this database with for ire cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ire

Every month we try and update this database with for ire cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ire cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.