NCT00019604

Radiofrequency Ablation in Treating Patients With Unresectable Primary or Metastatic Liver Cancer

The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: National Institutes of Health Clinical Center (CC) · NIH
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: * 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.

Conditions

• Liver Cancer
• Metastatic Cancer
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
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.

Timeline

• Start date: 1998-08-01
• Primary completion: 2009-01-01
• Completion: 2009-01-01
• First posted: 2003-01-27
• Last updated: 2017-02-03
• Results posted: 2014-06-12

Locations

1 site across 1 country: United States