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
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Enrollment
- 17
- Locations
- 1
- Primary Endpoint
- 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.
Study Overview
Brief Summary
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.
Detailed Description
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Diagnosis of primary renal cell carcinoma, hepatic metastases, or other solid tumor meeting the following criteria:
- •Not amenable to curative or substantial palliative therapy OR
- •Failed chemotherapy or biological response modifier therapy OR
- •Unlikely to benefit from conventional chemotherapy
- •No more than 5 measurable metastatic masses in the liver
- •No greater than 5 cm in diameter
- •Other tumor sites allowed if location and size amenable to ablation therapy
- •Measurable disease
- •PATIENT CHARACTERISTICS:
- •18 and over
- •Performance status:
- •Life expectancy:
- •More than 4 months
- •Hematopoietic:
- •Granulocyte count at least 1,000/mm^3
- •Hemoglobin at least 8.0 g/dL
- •Platelet count at least 100,000/mm^3
- •No untreated bleeding diathesis
- •PT no greater than 13.5 seconds
- •PT/PTT normal if prior warfarin or heparin use
- •Not specified
- •Cardiovascular:
- •No implanted pacemaker, incompatible aneurysm clip, or other device that would preclude magnetic resonance imaging
- •No myocardial infarction within the past 6 weeks
- •No unstable angina
- •Not pregnant or nursing
- •No serious active infection
- •PRIOR CONCURRENT THERAPY:
- •Biologic therapy:
- •See Disease Characteristics
- •At least 28 days since prior biological response modifier therapy
- •Chemotherapy:
- •See Disease Characteristics
- •At least 28 days since prior chemotherapy
- •Endocrine therapy:
- •Not specified
- •Radiotherapy:
- •No prior radiotherapy to study lesion
- •Not specified
- •At least 7 days since prior nonsteroidal antiinflammatory drugs or aspirin
- •At least 1 hour since prior heparin
- •No concurrent warfarin
- •No concurrent investigational drugs
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
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.
Time Frame: Patients are followed at 2 weeks and at 3, 6, 9, and 12 months.
Secondary Outcomes
No secondary outcomes reported