Thermal Ablation in Larger Liver and Kidney Tumours
Conditions
Liver and Kidney Tumours
Conditions: official terms
Kidney Neoplasms
Conditions: Keywords
Liver tumour, Kidney tumour, Hepatectomy, Nephrectomy, Metastatic Colon Cancer, Renal Cell Carcinoma
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: RFA Loosely wound thermal coil
Type: Device
Overall Status
Recruiting
Summary
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
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Location
University Health Network
Toronto, Ontario, Canada
Status: Recruiting
Start Date
August 2011
Completion Date
December 2015
Sponsors
University Health Network, Toronto
Source
University Health Network, Toronto
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page