Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000937910
Ethics application status
Approved
Date submitted
8/12/2008
Date registered
31/08/2011
Date last updated
31/08/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Irreversible Electroporation (IRE) for the treatment of focal liver, kidney and lung cancer ablation: a pilot study
Scientific title
Irreversible Electroporation (IRE) for the treatment focal liver, kidney and lung cancer ablation: a pilot study
Secondary ID [1] 262951 0
NA
Universal Trial Number (UTN)
Trial acronym
IRE study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Focal tumours of the liver 4093 0
Focal tumours of the lung 270681 0
Focal tumours of the kidney 270682 0
Condition category
Condition code
Cancer 4288 4288 0 0
Kidney
Cancer 270850 270850 0 0
Liver
Cancer 270851 270851 0 0
Lung - Small cell

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is ablation using Irreversible electroporation (direct current) which disrupts the cell membrane killing the tumour cells.

The whole procedure takes between 2 to 3 hours. Once the needle electrodes are in place the ablation takes approximately one minute. Depending on the size of the tumour the needle electrodes may be repositioned and further ablations (2 to approximately 10) may be performed. If complete ablation is not achieved a second procedure can be performed.
Intervention code [1] 3802 0
Treatment: Surgery
Comparator / control treatment
none
Control group
Uncontrolled

Outcomes
Primary outcome [1] 5173 0
Safety - Determined by the composite number of adverse events

The risks of ablation procedures include:

* Pain and nausea: nearly all patients experience some pain and nausea.

* Delayed ablation syndrome where you may have a fever/ malaise - 25%. Roughly one in four patients may develop a "post-ablation syndrome" with flu-like symptoms that appear three to five days after the procedure and usually last about five days. An occasional patient may remain ill for two to three weeks. Paracetamol taken by mouth is commonly used to control fever.

* For patients with lung tumours there is a 50% chance of pheumothorax . Pneumothorax is when air collects between the lung and inner chest and this causes the lung to collapse. This can be treated by placing a chest tube between the ribs into the space around the lungs to drain the air out of the space and to allow the lung to re-expand. If pneumothorax results you will be required to stay in hospital as an inpatient until the pneumothorax is resolved and the chest tube can be removed.

* Infection (very rare). Any procedure where the skin is penetrated carries a risk of infection. The chance of infection requiring antibiotic treatment appears to be less than one in 1,000.

* Post operative haemorrhage requiring transfusion (very rare). Some cases of bleeding have been reported but it usually stops on its own. If bleeding is severe, an additional procedure or surgery may be needed to control it.

* Injury to surrounding tissue (none noted to date in animal studies and human prostate studies of the Angiodynamics System). RFA however, because it relies on heat to damage cells, depending on the site of treatment, it may cause brief or, rarely, long-lasting shoulder pain; inflammation of the gallbladder that subsides after a few weeks; damage to the bile ducts resulting in biliary obstruction - a blockage in the tubes that carry a liquid called bile from the liver to the gallbladder and small intestine; this liquid helps digest fat. An operation may be needed to rectify the problem; or thermal damage to the bowel (3-5%).

* Death (extremely rare).

Having a drug injected or blood taken may cause some discomfort or bruising. Sometimes, the blood vessel may swell, or blood may clot in the blood vessel, or the spot from which tissue is taken could become inflamed. Rarely, there could be a minor infection or bleeding. If this happens, it can be easily treated.

Medical treatments often cause side effects. You may have none, some or all of the effects listed above, and they may be mild, moderate or severe. If you have any of these side effects, or are worried about them, talk with your doctor. Your doctor will also be looking out for side effects.

Many side effects go away shortly after treatment ends. However, sometimes side effects can be serious, long lasting or permanent. If a severe side effect or reaction occurs. Tell your doctor if you have any problems. Your doctor will discuss the best way of managing any side effects with you

Computer Tomography (CT) imaging uses X-rays and therefore exposes you to ionising radiation. Ionising radiation represents a significant risk to unborn children. Therefore, all women of childbearing age will be screened for pregnancy. This screening is standard procedure for all women of childbearing age prior to undergoing a X-ray or CT. This screening may include a blood or urine pregnancy test. If you think that you may be pregnant or plan to become pregnant you should not participate in this study. If you become pregnant during this study, immediately contact your research doctor.
Timepoint [1] 5173 0
Procedure, 1 month, 6 months
Primary outcome [2] 279530 0
Efficacy of ablation - Determined by contrast enhanced computer tomography
Timepoint [2] 279530 0
At one then every 3 months post procedure
Secondary outcome [1] 8707 0
n/a
Timepoint [1] 8707 0
n/a

Eligibility
Key inclusion criteria
Ages 35-85 years, Signed informed consent, Failed conventional treatment, Ability to visualize cancer foci adequately on imaging.
Minimum age
35 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients not deemed suitable for ablation procedure.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
10/11/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4259 0
Other
Name [1] 4259 0
Angiodynamics Inc.
Country [1] 4259 0
United States of America
Primary sponsor type
Hospital
Name
The Alfred Hospital
Address
The Alfred Hospital Melbourne, Vic 3004
Country
Australia
Secondary sponsor category [1] 3832 0
None
Name [1] 3832 0
Address [1] 3832 0
Country [1] 3832 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6310 0
The Alfred HREC
Ethics committee address [1] 6310 0
Commercial Road
Melbourne, Vic 3004
Ethics committee country [1] 6310 0
Australia
Date submitted for ethics approval [1] 6310 0
Approval date [1] 6310 0
18/09/2008
Ethics approval number [1] 6310 0
1/08/0204

Summary
Brief summary
In cases where patients have inoperable tumours, direct destruction of focal tumours using various energy sources such as heat (radiofrequency ablation, microwaves), cold (cryotherapy) or ethanol injection have been used for the last twenty years. A needle is placed into the tumour under image guidance in a similar way to taking a biopsy. The energy used, heat or cold, destroys the tumour. Currently not all inoperable tumours can be treated in this way because tumours may lie close to vital structures that may be affected and therefore pose a large risk to patients. The new technology, irreversible electroporation, does not use heat or cold and therefore spares vital structures. Direct electrical current is used to destroy the outer membrane of the tumour cells. We are testing the safety and effectiveness of this form of ablation.
Trial website
Trial related presentations / publications
Thomson KR, Cheung W, Ellis SJ, Federman D, Kavnoudias H, Loader-Oliver D, Roberts S, Evans P, Ball C, Haydon A. Investigation of the Safety of Irreversible Electroporation in Humans. J Vasc Interv Radiol 2011 May;22(5):611-21
Public notes

Contacts
Principal investigator
Name 35015 0
Address 35015 0
Country 35015 0
Phone 35015 0
Fax 35015 0
Email 35015 0
Contact person for public queries
Name 12362 0
Helen Kavnoudias
Address 12362 0
Radiology Department
The Alfred
Commercial Road
Melbourne, VIC 3004
Country 12362 0
Australia
Phone 12362 0
+61 3 9076 3606
Fax 12362 0
+61 3 9076 2153
Email 12362 0
[email protected]
Contact person for scientific queries
Name 3290 0
Helen Kavnoudias
Address 3290 0
The Alfred
Commercial Road
Melbourne, Vic 3004
Country 3290 0
Australia
Phone 3290 0
+61 3 9076 3606
Fax 3290 0
+61 3 9076 2153
Email 3290 0
[email protected]

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No Supporting Document Provided



Results publications and other study-related documents

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