Effect of Lithium Carbonate on Low-Dose Radioiodine Therapy in Early Thyroid Cancer
Completed · Phase 2 · Has a placebo group
Conditions studied: Thyroid Cancer, Differentiated Thyroid Carcinoma
In brief
This study will examine the safety and effectiveness of using lithium, which has been used to enhance the effectiveness of high-dose 131I, with a single low dose (30 mCi) of 131I for thyroid ablation in patients with recently diagnosed papillary or follicular thyroid cancer who have had their thyroid gland removed and whose cancer has not spread beyond the thyroid. 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.
Key facts
- Study ID
- NCT00251316
- Run by
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- People needed
- 34
- Starts
- 2005-11-01
- Expected to finish
- 2011-12-01
- Last updated by the study team
- 2013-02-04
Who can join
Age: 16 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States
Full record on ClinicalTrials.gov
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