Status:
COMPLETED
Effect of Lithium Carbonate on Low-Dose Radioiodine Therapy in Early Thyroid Cancer
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Thyroid Cancer
Differentiated Thyroid Carcinoma
Eligibility:
All Genders
16+ years
Phase:
PHASE2
Brief Summary
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 ...
Detailed Description
Postsurgical thyroid remnant ablation with (131)I is considered standard clinical care for most cases of papillary and follicular thyroid cancer, to eliminate normal thyroid tissue which may contain m...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00251316
Start Date
November 1 2005
End Date
December 1 2011
Last Update
February 4 2013
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892