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
Radiation: gadopentetate dimeglumine
|Study Design:||Primary Purpose: Treatment|
|Official Title:||The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms|
- Nature and duration of response [ Designated as safety issue: No ]
- Treatment effects [ Designated as safety issue: No ]
- Response as measured by positron emission tomography with fludeoxyglucose F 18 (FDG-PET) after treatment [ Designated as safety issue: No ]
- Comparison of FDG-PET results with CT scan, biopsy, and serum marker results [ Designated as safety issue: No ]
- Comparison of FDG-PET performance with CT scan and MRI performance in assessing efficacy of study treatment [ Designated as safety issue: No ]
|Study Start Date:||August 1998|
|Primary Completion Date:||January 2009 (Final data collection date for primary outcome measure)|
- 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.
|United States, Maryland|
|Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office|
|Bethesda, Maryland, United States, 20892-1182|
|Study Chair:||Steven K. Libutti, MD||NCI - Surgery Branch|