Thyroid Cancer Clinical Trial
Official title:
The Effects of Lithium Carbonate on Low Dose Radioiodine Ablation in Early Thyroid Cancer Treatment
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.
Status | Completed |
Enrollment | 34 |
Est. completion date | December 2011 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years and older |
Eligibility |
- INCLUSION CRITERIA 1. 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 2. Patients younger than 45 years with any size of primary papillary or follicular tumor 3. Patients older than 45 years with: 1. primary papillary tumor less than 4 cm or 2. primary follicular tumor less than 1 cm - EXCLUSION CRITERIA 1. Patients with postsurgical thyroid remnant more than 5 g 2. Patients with distant metastases 3. Patients above 45 years of age having: 1. known cervical lymph nodes metastases 2. microscopic multifocal follicular cancer 3. microscopic extraglandular invasion of follicular cancer 4. gross extraglandular invasion of papillary or follicular cancer 4. Patients with confirmed histological subtypes of well-differentiated thyroid cancer such as Hurtle cell carcinoma, insular and tall cell variants of papillary cancer. 5. Pregnant or lactating women 6. Patients with renal impairment defined as repeat serum creatinine concentrations above 1.5 mg/dl on thyroid hormone 7. Patients on chronic lithium therapy for psychiatric illness 8. Patients with current unstable cardiovascular conditions 9. Patients with severe chronic medical conditions (liver failure, severe debilitation, dehydration, sodium depletion, any other cancer requiring therapy, etc) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Mazzaferri EL, Jhiang SM. Long-term impact of initial surgical and medical therapy on papillary and follicular thyroid cancer. Am J Med. 1994 Nov;97(5):418-28. Erratum in: Am J Med 1995 Feb;98(2):215. — View Citation
Mazzaferri EL. An overview of the management of papillary and follicular thyroid carcinoma. Thyroid. 1999 May;9(5):421-7. Review. — View Citation
Sherman SI. Thyroid carcinoma. Lancet. 2003 Feb 8;361(9356):501-11. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The Rate of Successful Thyroid Ablation as Defined by Negative Recombinant Human Thyrotropin (rhTSH) Stimulated Radioiodine Whole Body Scan (RAI WBS) at 1 Year. | 1 year | No |
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