Protocol Number: 04-C-0263
Patients 18 years of age and older who have inoperable liver cancer may be eligible for this study. Candidates are screened with a medical history, physical examination, blood tests, electrocardiogram (EKG), and computed tomography (CT), positron emission tomography (PET), and magnetic resonance imaging (MRI) scans. These tests are repeated at various intervals during the study to monitor disease progress. CT is an x-ray test that provides detailed pictures of the inside of the body. The patient lies on a table that moves into the middle of a large, donut-shaped scanner. The scanner can move around the body to take pictures at different angles, which are viewed on a computer monitor. PET can be used to detect tumors and may be useful for determining the extent of disease and response to treatment. The patient is given an injection of a glucose (sugar) solution called fluorodeoxyglucose (FDG) in which a radioactive "tracer" has been attached to the glucose molecule. A special camera detects the radiation emitted by the FDG, and the resulting images show how much glucose is being used by the cells. Because rapidly growing cells, such as cancer cells, take up and use more glucose than normal cells do, this test can show tumor activity. MRI uses a magnetic field and radio waves to produce images of body tissues and organs. For this procedure, the patient lies on a table that is moved into the scanner (a narrow cylinder), wearing earplugs to muffle loud knocking sounds that occur during the scanning process. During some of the scan, patients may be asked to hold their breath. Flow studies of the tumor blood vessels may also be obtained with an EKG or a finger probe. Participants receive Thermodox, infused over 30 minutes through a catheter (thin plastic tube) placed in a vein. The first group of patients entering the study receives the lowest dose of Thermodox; subsequent groups receive increasingly higher doses as long as the side effects remain tolerable and until a maximum dose is reached. Other medicines, including dexamethasone, ranitidine, and benadryl, are given before the Thermodox dose to prevent some side effects and allergic reactions to the drug. About 15 minutes after the Thermodox is started, the RFA needle is placed in the liver tumors in one of three ways: through the skin (percutaneously); through a tube placed in a small hole cut in the abdomen (laparoscopy); or through an open incision during surgery. The needle points are heated to a high temperature for about 5 minutes to destroy the tumor cells. The total time of the RFA procedure averages from 12 to 60 minutes, depending on the number and size of tumors. Patients remain in the hospital for about 48 hours and are monitored with frequent blood and urine tests. After discharge, they have blood drawn weekly and they return to NIH after 4 weeks for tumor evaluation with scans, X-rays, and blood tests. The scans and blood tests are repeated every 3 months for the first year and then every 6 months for a total of 3 years, or until the tumors begin to grow.
Search The Studies | Help | Questions |
National Institutes of Health Clinical Center |
||