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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
History of Changes
  Purpose

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


Condition Intervention
Liver and Kidney Tumours
 Device: RFA Loosely wound thermal coil

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 12
Study Start Date: August 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acute
the RFA thermal coil will take place at the time of surgery, just prior to tumour removal
 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: Delayed
The RFA thermal coil procedure will occure 6-10 days prior to the surgery for tumour removal
 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01720706

Contacts
Contact: Laura Legere, BScN 416-946-2282 laura.legere@uhn.ca

Locations
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5g 2M9
Sponsors and Collaborators
University Health Network, Toronto
Investigators
Principal Investigator: Michael Jewett, M.D. University Health Network, Toronto
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT01720706     History of Changes
Other Study ID Numbers: RFA
Study First Received: October 29, 2012
Last Updated: October 31, 2012
Health Authority: Canada: Research Ethics Committee

Keywords provided by University Health Network, Toronto:
Liver tumour
Kidney tumour
Hepatectomy
 Nephrectomy
Metastatic Colon Cancer
Renal Cell Carcinoma

Additional relevant MeSH terms:
Kidney Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
 Neoplasms
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 22, 2013