Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer
RATIONALE: Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
PURPOSE: Phase II trial to study the effectiveness of radiofrequency ablation in treating patients who have unresectable primary or metastatic liver cancer.
Unspecified Adult Solid Tumor, Protocol Specific
Procedure: computed tomography
Procedure: magnetic resonance imaging
Procedure: positron emission tomography
Procedure: radiofrequency ablation
Procedure: radionuclide imaging
Procedure: ultrasound imaging
Radiation: fludeoxyglucose F 18 (FDG-PET)
Radiation: gadopentetate dimeglumine
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms|
- Response [ Designated as safety issue: No ]Standard response criteria will be used to assess the CT (computed tomography) scan images on a lesion per lesion basis. Complete response is complete disappearance of the index lesion on followup scan when compared tot eh pretreatment images. Partial response is a decrease of 50% or greater in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Minor response is a decrease between 25% and 49% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images. Stable disease is no change in the size of the treated lesion. Progressive disease is an increase of greater than 25% in the product of the perpendicular diameters of the measured lesion following treatment compared to the pretreatment images.
- Number of Participants With Adverse Events [ Time Frame: 9 years, 9 months ] [ Designated as safety issue: Yes ]Here is the number of participants with adverse events. For a detailed list of adverse events see the adverse event module.
|Study Start Date:||August 1998|
|Study Completion Date:||January 2009|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
Experimental: Radiofrequency ablation in liver cancer
This trial is designed to gain experience with the use of ablation devices with liver tumors. Radiofrequency ablation is a procedure that heats tumors to several degrees above body temperature and may kill tumor cells.
Procedure: computed tomography
Scan to assess the effects of ablation.Procedure: magnetic resonance imaging
Imaging used to assess the effects of this ablative therapy on tumor vascular density.Procedure: positron emission tomography
Physiology based method of imaging disease based on uptake and metabolism of radiopharmaceutical by the tissues.Procedure: radiofrequency ablation
Radiofrequency ablation uses saline infusion into and out of needle/electrode through a closed system. More energy may be deposited without tissue-charring or gas vaporization.Procedure: radionuclide imaging
Imaging following injection of a radioactive material.Procedure: ultrasound imaging
An ultrasound (e.g. sound waves) is used to identify the lesion and needle placement.Radiation: fludeoxyglucose F 18 (FDG-PET)
FDG PET scans rely on metabolic changes to evaluate response to therapy.Radiation: gadopentetate dimeglumine
Food and Drug Administration approved contrast agent.
- Evaluate the nature and duration of response of patients with primary or metastatic liver neoplasms, who are not candidates for surgical resection, treated with radiofrequency interstitial tissue ablation.
- Evaluate the ability of dynamic magnetic resonance imaging (MRI) to assess the effects of this therapy on tumor blood flow and tumor vascular density in these patients.
- Determine the ability of positron emission tomography with fludeoxyglucose F 18 (FDG-PET) to monitor response after treatment with this therapy in these patients.
- Compare FDG-PET results with computed tomography (CT) scan, biopsy, and serum marker results in patients treated with this therapy.
- Compare the performance of FDG-PET with CT scan and MRI, in terms of their ability to assess the efficacy of this therapy in these patients.
OUTLINE: Lesions are targeted by ultrasound and then radiofrequency ablation needles are inserted into the lesions and heated to a target temperature greater than 60 degrees C for 15 minutes, though exposure time may vary depending on temperatures achieved. To achieve a 1 cm margin of ablated tissue around each lesion, multiple ablation courses may be performed, depending on the size of the lesions and the time required to complete the treatment.
Patients undergo magnetic resonance imaging with gadopentetate dimeglumine contrast, CT scan, ultrasound, and positron emission tomography with fludeoxyglucose F 18 at baseline, 6 weeks, every 3 months for 1 year, and then every 6 months for 2 years.
Patients are followed at 6 weeks, every 3 months for 1 year, and then every 6 months for 2 years or until evidence of recurrence.
PROJECTED ACCRUAL: A total of 58 patients will be accrued for this study within 6 years.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00019604
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|Principal Investigator:||Steven A Libutti, MD||National Cancer Institute, National Institutes of Health|