Pilot study comparing needle placement for Irreversible Electroporation (IRE) using CT navigation versus conventional CT-guidance

• Register: ISRCTN
• Last refreshed on: 26 June 2023
• Main ID: ISRCTN55383115
• Date of registration: 09/05/2016
• Prospective Registration: No
• Primary sponsor: University Hospital Regensburg
• Public title: Pilot study comparing needle placement for Irreversible Electroporation (IRE) using CT navigation versus conventional CT-guidance
• Scientific title: Pilot study comparing needle placement for Irreversible Electroporation (IRE) using CT navigation versus conventional CT-guidance: a non-randomized prospective two-arm study
• Date of first enrolment: 01/07/2015
• Target sample size: 20
• Recruitment status: Completed
• URL: https://www.isrctn.com/ISRCTN55383115
• Study type: Interventional
• Study design: Non-randomized prospective two-arm study. (Treatment)
• Phase: Not Applicable

Countries of recruitment

Germany

Contacts

• Name: Lukas Beyer

Key inclusion & exclusion criteria

Inclusion criteria: 1. Patients must be scheduled for CT guided percutaneous IRE in the liver
2. Written informed consent
3. Male patients and non-pregnant, non-lactating females aged =18 years of age (negative serum/urine pregnancy test result at screening)
Exclusion criteria: 1. Any condition which, in the judgment of the clinical investigator or his designee, might increase the risk to the subject or decrease the chance of obtaining satisfactory data to achieve the objectives of the study
2. A mental condition rendering the patient unable to provide informed consent
3. Patients with hereditary haematological / coagulation disorders unrelated to their liver disease.
4. Patients who are currently (within the last 30 days prior to surgery) participating in another clinical trial with any investigational drug or device
5. Patients undergoing liver surgery for the purpose of receiving a liver transplant or for liver trauma
6. Patients with established renal insufficiency (Creatinine >2.5 mg/dl), or a condition requiring hemodialysis

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Liver cancer
Cancer

Intervention(s)

Irreversible Electroporation (IRE) is a novel method for focused treatment of liver tumors. IRE is a soft tissue ablation technique using ultra short but strong electrical fields to create permanent and hence lethal nanopores in the cell membrane, to disrupt the cellular homeostasis. The resulting cell death results from apoptosis and not necrosis as in all other thermal or radiation based ablation techniques. IRE is used for non-resectable liver tumors in the vicinity of vessels (due to the its selectivity for tumor tissue while preserving vessel structures).

IRE ablation requires the placement of two or more applicator electrodes between which the electrical fields are applied. In order to achieve successful ablation, parallel needle placement at a pre-defined distance is required. Needles are placed under image guidance using ultrasound or computer tomography as imaging methods. As these methods are displaying one image plane at a time, the realization of multiple needle placements can be challenging and can require several attempts until the required geometrical configuration of the needle with respect to other needles and also to the anatomical target is achieved.
Navigation technology for interventional radiology supports IRE treatments by providing comprehensive planning of needle configurations using 3D image data and by supporting needle placement through guidance functionality.

This study aims to investigate the potential benefits of CT-navigated IRE needle placement compared to conventional non-navigated techniques.

Primary Outcome(s)

Time required for the placement of IRE needles (measured from the time of the first CT scan to the start of the ablation).

Secondary Outcome(s)

1. Accuracy of IRE needle placement compared to a patient-specific ablation strategy (accuracy is measured as distance to the target point, distance between needles, angles between needles)
2. Overall procedure time
3. Number of lesions treated per patient
4. Number of needle replacements
5. Number of control scans
6. Radiation dose

Secondary ID(s)

1.0

Source(s) of Monetary Support

Universitätsklinikum Regensburg

Ethics review

Status:
Approval date:
Contact:

Old ethics approval format; University Hospital Regensburg (02/2015).

Results

• Results available: Yes
• Date Completed: 01/03/2016