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Sponsors and Collaborators: |
NCI - Center for Cancer Research-Medical Oncology National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00019604 |
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.
Condition | Intervention | Phase |
Liver Cancer Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific |
Drug: fludeoxyglucose F 18 Drug: gadopentetate dimeglumine Procedure: computed tomography Procedure: magnetic resonance imaging Procedure: positron emission tomography Procedure: radiofrequency ablation Procedure: radionuclide imaging Procedure: ultrasound imaging |
Phase II |
MedlinePlus related topics: | CT Scans Cancer Liver Cancer MRI Scans Nuclear Scans |
Drug Information available for: | Fluorodeoxyglucose F18 Gadolinium dtpa |
Study Type: | Interventional |
Study Design: | Treatment |
Official Title: | The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms |
Estimated Enrollment: | 58 |
Study Start Date: | August 1998 |
OBJECTIVES:
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed primary or metastatic liver lesions
PATIENT CHARACTERISTICS:
Age:
Performance status:
Life expectancy:
Hematopoietic:
Hepatic:
Renal:
Other:
PRIOR CONCURRENT THERAPY:
Biologic therapy:
Chemotherapy:
Endocrine therapy:
Radiotherapy:
Surgery:
Other:
United States, Maryland | |||||
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | |||||
Bethesda, Maryland, United States, 20892-1182 |
NCI - Center for Cancer Research-Medical Oncology |
National Cancer Institute (NCI) |
Study Chair: | Steven K. Libutti, MD | NCI - Surgery Branch |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000066875, NCI-99-C-0025 |
First Received: | July 11, 2001 |
Last Updated: | October 18, 2008 |
ClinicalTrials.gov Identifier: | NCT00019604 |
Health Authority: | United States: Food and Drug Administration |
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