Thermal Ablation in Larger Liver and Kidney Tumours

This study is currently recruiting participants.
Verified October 2012 by University Health Network, Toronto
Sponsor:
Information provided by:
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01720706
First received: October 29, 2012
Last updated: October 31, 2012
Last verified: October 2012

October 29, 2012
October 31, 2012
August 2011
August 2013   (final data collection date for primary outcome measure)
RF electrodes can be accurately and safely placed in the desired location [ Time Frame: up to 10 days prior to surgery and up to 24 hrs after surgery ] [ Designated as safety issue: Yes ]
this will be assessed during the surgery and once the tumour is removed and examined
Same as current
Complete list of historical versions of study NCT01720706 on ClinicalTrials.gov Archive Site
  • The safety of energy application with the RF coil device including assessing effect on surrounding liver tissue [ Time Frame: up to 10 days prior to surgery and up to 24 hrs after surgery ] [ Designated as safety issue: Yes ]
    This will be assessed during the surgery and once the tumour is removed and examined
  • Verifying that large (>2cm) liver tumors are effectively ablated with RF energy [ Time Frame: up to 24hrs after surgery ] [ Designated as safety issue: Yes ]
    Once the tumour is removed, the ablation field can be fully examined.
Same as current
Not Provided
Not Provided
 
Thermal Ablation in Larger Liver and Kidney Tumours
Thermal Ablation With a Loosely Wound Helical Coil for Radiofrequency Treatment of Large Renal and Hepatic Tumors in Patients Undergoing Partial or Total Nephrectomy or Heptectomy

This is a clinical research study designed to determine the safety and efficacy of the application of a unique interstitial radio frequency thermal therapy for the treatment of large tumours in the kidney or liver. The novel device offers patients a more effective therapy than conventional RFA and for patients with large tumours fewer number of treatments and needle insertion sites. The clinical treatment volumes (or sites of focal tumours) will be determined by a combination of biopsy and contrast enhanced CT imaging.

The study will assess if novel device can produce lesions in the liver or kidney in a controlled and predictable manner and with sufficient size to effectively manage disease progression in the organ. The extent of lesion size at a delivered power setting and treatment time will be measured with post-treatment CT or MRI and biopsy as measures of tissue response

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Liver and Kidney Tumours
Device: RFA Loosely wound thermal coil

This new device uses radiofrequency energy to destroy kidney or liver tumours. It is called radiofrequency ablation.

This type of energy is simply an alternating current that passes from a coil (electrode) into the tissue causing heating of the tissue in the vicinity of the electrode.

Other Name: This device has been developed by the University Health Network
  • Experimental: Acute
    the RFA thermal coil will take place at the time of surgery, just prior to tumour removal
    Intervention: Device: RFA Loosely wound thermal coil
  • Experimental: Delayed
    The RFA thermal coil procedure will occure 6-10 days prior to the surgery for tumour removal
    Intervention: Device: RFA Loosely wound thermal coil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
12
December 2013
August 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • subjects with a solid renal mass who are undergoing partial or radical nephrectomy
  • subjects with a solid hepatic masses of heptacellular carcinoma or metastatic liver tumour booked for partial or radical hepatectomy

Exclusion Criteria:

  • irreversible coagulation defects,
  • hepatic infection,
  • no extra hepatic malignant disease,
  • venous invasion and/or
  • morbid obesity
Both
18 Years and older
No
Contact: Laura Legere, BScN 416-946-2282 laura.legere@uhn.ca
Canada
 
NCT01720706
RFA
No
Not Provided
University Health Network, Toronto
Not Provided
Principal Investigator: Michael Jewett, M.D. University Health Network, Toronto
University Health Network, Toronto
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP