We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Thermal Ablation in Larger Liver and Kidney Tumours

This study is currently recruiting participants.
Verified June 2017 by University Health Network, Toronto
Sponsor:
ClinicalTrials.gov Identifier:
NCT01720706
First Posted: November 2, 2012
Last Update Posted: June 2, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
University Health Network, Toronto
  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
Intervention Model: Parallel Assignment
Masking: None (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:


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 ]
    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 ]
    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 ]
    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 2017
Estimated Primary Completion Date: August 2017 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Acute
The RFA Loosely wound thermal coil electrode will be inserted directly or percutaneously into the lesion, depending on the imaging modality (US or CT guidance) and deployed with same method as previously described in the 'delayed group'. Energy will be delivered using the single timed heating cycle. Treatment will be monitored with B mode US. Once the cycle is completed, the probe will be removed and the planned surgery will continue with partial or radical nephrectomy.
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: Devicedeveloped by the University Health Network
Experimental: Delayed
Using an electrically insulated 12ga introducer with trocar is inserted percutaneously into the renal tumor. The needle tip will be placed 20mm from the center of the target. The trocar is removed and co-axially (i.e. within the introducer), a core biopsy of the lesion is performed with a 14-18 gauge needle. The radiofrequency applicator with a 14ga cannula containing the RFA Loosely wound thermal coil electrode is then optimally positioned and locked into the introducer. On approximately day 6-10, a partial or radical nephrectomy will be performed in the usual way.
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: Devicedeveloped by the University Health Network

  Show Detailed Description

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01720706     History of Changes
Other Study ID Numbers: RFA
First Submitted: October 29, 2012
First Posted: November 2, 2012
Last Update Posted: June 2, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

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