Effect of Lithium Carbonate on Low-Dose Radioiodine Therapy in Early Thyroid Cancer
Thyroid Cancer, Differentiated Thyroid Carcinoma
About this trial
This is an interventional treatment trial for Thyroid Cancer focused on measuring Thyroid Neoplasm, I-131, Radiation Dose, Radiation Effect, Pharmaceutical Adjuvant, Thyroid Cancer
Eligibility Criteria
INCLUSION CRITERIA Patients older than 16 years with well-differentiated papillary or follicular thyroid cancer stage I or II, according to the NTCTCS classification at time of surgery Patients younger than 45 years with any size of primary papillary or follicular tumor Patients older than 45 years with: primary papillary tumor less than 4 cm or primary follicular tumor less than 1 cm EXCLUSION CRITERIA Patients with postsurgical thyroid remnant more than 5 g Patients with distant metastases Patients above 45 years of age having: known cervical lymph nodes metastases microscopic multifocal follicular cancer microscopic extraglandular invasion of follicular cancer gross extraglandular invasion of papillary or follicular cancer Patients with confirmed histological subtypes of well-differentiated thyroid cancer such as Hurtle cell carcinoma, insular and tall cell variants of papillary cancer. Pregnant or lactating women Patients with renal impairment defined as repeat serum creatinine concentrations above 1.5 mg/dl on thyroid hormone Patients on chronic lithium therapy for psychiatric illness Patients with current unstable cardiovascular conditions Patients with severe chronic medical conditions (liver failure, severe debilitation, dehydration, sodium depletion, any other cancer requiring therapy, etc)
Sites / Locations
- National Institutes of Health Clinical Center, 9000 Rockville Pike
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Lithium Carbonate
Placebo
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. Participants in this arm receive lithium capsules.
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. Participants in this arm receive placebo (look-alike capsules with no active ingredient).