Trial Information

The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms

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 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.