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The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms



The Use of Radiofrequency Ablation to Treat Hepatic Neoplasms

For Condition: Liver Neoplasm
Status: Recruiting
Sponsor(s): National Cancer Institute (NCI) ,
Synopsis: The Radiofrequency Interstitial Tissue Ablation (RITA) unit and the Radionics CC-1 Cosman Coagulator system, and LeVeen electrodes and RF 2000 generator of the RadioTherapeutics RF Ablation System are FDA approved devices for the treatment of soft tissue. They use a modification of the standard surgical electrocautery that uses heat to destroy tissue. They have incorporated several improvements including multi-tipped cautery needles for the treatment of a larger volume of tissue as well as thermistors built into the tips which allow for accurate control of tissue temperature. There is already a large experience with these devices for the treatment of hepatic neoplasms. This protocol is designed to allow us to gain experience using these devices as well as to evaluate the use of various imaging modalities to determine tissue responses.
Details: The Radiofrequency Interstitial Tissue Ablation (RITA) unit, the Radionics CC-1 Cosman Coagulator system, and LeVeen electrodes and RF 2000 generator of the RadioTherapeutics RF Ablation System are FDA approved devices for the treatment of soft tissue. They use a modification of the standard surgical electrocautery that uses heat to destroy tissue. They have incorporated several improvements including multi-tipped cautery needles for the treatment of a larger volume of tissue as well as thermistors built into the tips which allow for accurate control of tissue temperature. There is already a large experience with these devices for the treatment of hepatic neoplasms. This protocol is designed to allow us to gain experience using these devices as well as to evaluate the use of various imaging modalities to determine tissue responses.
Eligibility:
Study Type:  Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Patients with either primary or metastatic liver lesions who are not candidates for surgical resection either due to tumor histology, previous surgery, concomitant medical conditions or multi-site disease. Biopsy proven evidence of cancer. Patients with 6 or fewer lesions and with no single lesion greater than 7 cm in maximum diameter. Age greater than or equal to 18 years. Patients must be willing to return to NIH for their imaging scans. Patient must be able to sign informed consent. Life expectancy greater than or equal to 3 months. ECOG performance status 0-2. Patients with extrahepatic disease in addition to their hepatic metastases are eligible and may receive systemic therapy for their extrahepatic disease. EXCLUSION CRITERIA: Patients who are candidates for complete surgical resection. Pregnancy or breast-feeding. A negative pregnancy test (urine or serum) is required prior to enrollment. Known uncontrollable serious reactions such as anaphylaxis, to the contrast agents used in this study. Patients with pacemakers, cerebral aneurysm clips, shrapnel injury or implantable electronic devices. PT or PTT greater than 1.5X control (except in patients who are therapeutically anticoagulated for non-related medical conditions such as atrial fibrillation). Platelet count less than 50,000. Total bilirubin greater than 3.0. Serum creatinine greater than 2.5. Patients who weigh greater than or equal to 136 kg (weight limit for the PET scanner table). Patients with uncontrolled glucose due to diabetes may be studied, but will be evaluated separately.
Total Enrollment: 58

Location and Contact Information:

National Cancer Institute (NCI) *Recruiting*
Bethesda,  Maryland,  20892
United States
Recruiting Clinical  Support Center/NCI 1-888-624-1937


Additional Information:
Study ID Numbers:  990025;  99-C-0025
Study Start Date: December 23, 1998
Record last reviewed: December 1, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001795

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