Unspecified Adult Solid Tumor, Protocol Specific Clinical Trial
Official title:
A Phase II Study of Magnetic Resonance Guided and Monitored Interstitial Thermal Radiofrequency Ablation of Primary Renal Cell Carcinoma, Hepatic Metastasis, and Other Sites of Solid Organ Tumor and Metastases
RATIONALE: Radiofrequency ablation uses high-frequency electric current to heat and kill
tumor cells. Magnetic resonance imaging-guided radiofrequency ablation may an effective
treatment for primary kidney cancer, liver metastases, or other solid tumors.
PURPOSE: Phase II trial to study the effectiveness of magnetic-resonance-guided
radiofrequency ablation in treating patients who have primary kidney cancer, liver
metastases, or other solid tumors.
OBJECTIVES:
- Determine whether magnetic resonance image monitoring during radiofrequency
interstitial thermal ablation can accurately predict complete destruction of focal
tumor along with an adequate margin of normal tissue, as demonstrated by absence of
growth on subsequent imaging studies for a 1-year period, in patients with primary
renal cell carcinoma, hepatic metastases, or other solid tumors.
OUTLINE: Patients are stratified according to disease (localized hepatic metastases vs
primary renal neoplasms vs solid tumors in other sites).
Patients undergo thermal ablation by radiofrequency energy under magnetic resonance
guidance. Thermal ablation continues until the entire tumor is treated. Treatment ceases
when the entire lesion has undergone necrosis or the zone of necrosis or significant heat
deposition approaches vital neurovascular structures.
Patients are followed at 2 weeks and at 3, 6, 9, and 12 months.
PROJECTED ACCRUAL: A total of 28-39 patients will be accrued for this study within 22-36
months.
;
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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