Protocol Number: 06-DK-0025
Patients recently diagnosed with papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid may be eligible for this study. Candidates are screened with a medical history, physical examination, blood tests, thyroid ultrasound and chest x-ray. Participants are randomly assigned to receive lithium capsules or placebo (look-alike capsules with no active ingredient). They follow a low-iodine diet for 2 weeks before starting treatment and are then admitted to the NIH Clinical Center for study and treatment for 11 days, during which they remain on the low-iodine diet. Blood samples are collected almost every day to analyze thyroid hormones, kidney and liver function, lithium concentrations and other tests. On day 2 of hospitalization, patients have a whole-body scan to determine how much functional thyroid remained after surgery and to rule out spread of the cancer. For 2 days before the scan, they receive an injection of recombinant thyroid stimulating hormone (TSH), a laboratory-made drug that is almost identical to the TSH normally made by the pituitary gland. Then they swallow a capsule containing a small amount of 131I, which is used for imaging the thyroid. A special camera takes pictures of the neck after 4 hours and after 24 hours. TSH injections are repeated for 2 more days to prepare for therapy with 131I. On about day 7 of hospitalization, patients take a capsule containing low-dose 131I. Each remaining day in the hospital, patients have additional blood tests to measure the level of radioactivity and scans to evaluate the effectiveness of lithium or placebo and low-dose 131I for ablation. On the last day in the hospital, patients stop taking lithium or placebo and have a repeat scan to make sure that the cancer has not spread outside the thyroid gland. After discharge from the hospital, patients have the following procedures: -After 3 to 6 months: Questionnaire about their health -After 6 months: Physical examination and blood tests -After 1 year: Repeat scan and blood tests after eating a low-iodine diet for 2 weeks and receiving two recombinant TSH injections
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National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 01/30/2009
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