Magnetic Resonance Imaging-guided Thermal Radiofrequencey Ablation of Primary Renal Cell Carcinoma, Hepatic Metastasis, and Other Sites of Solid Organ Tumor and Metastases

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00006255
First received: September 11, 2000
Last updated: June 9, 2010
Last verified: June 2010

September 11, 2000
June 9, 2010
April 2000
March 2005   (final data collection date for primary outcome measure)
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. ] [ Designated as safety issue: No ]
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Complete list of historical versions of study NCT00006255 on ClinicalTrials.gov Archive Site
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Magnetic Resonance Imaging-guided Thermal Radiofrequencey Ablation of Primary Renal Cell Carcinoma, Hepatic Metastasis, and Other Sites of Solid Organ Tumor and Metastases
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.

Interventional
Phase 2
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Kidney Cancer
  • Metastatic Cancer
  • Unspecified Adult Solid Tumor, Protocol Specific
  • Procedure: radiofrequency ablation
    Undergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated.
  • Procedure: thermal ablation therapy
    Undergo thermal ablation by radiofrequency energy under magnetic resonance guidance.Thermal ablation continues until the entire tumor is treated.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
17
March 2005
March 2005   (final data collection date for primary outcome measure)

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:

Age:

  • 18 and over

Performance status:

  • ECOG 0-2

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

Hepatic:

  • PT no greater than 13.5 seconds
  • PT/PTT normal if prior warfarin or heparin use

Renal:

  • 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

Other:

  • 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

Surgery:

  • Not specified

Other:

  • 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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00006255
CWRU2Y00, P30CA043703, CWRU-2Y00, NCI-G00-1850
Yes
John R. Haaga, MD, Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Study Chair: John R. Haaga, MD Ireland Cancer Center at University Hospitals Case Medical Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
June 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP