Ignite Creation Date:
2024-05-05 @ 12:09 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00251316
Status:
COMPLETED
Last Update Posted:
2013-02-04
First Post:
2005-11-09
Brief Title:
Effect of Lithium Carbonate on Low-Dose Radioiodine Therapy in Early Thyroid Cancer
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
The Effects of Lithium Carbonate on Low Dose Radioiodine Ablation in Early Thyroid Cancer Treatment
Status:
COMPLETED
Status Verified Date:
2013-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 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
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
Detailed Description:
Postsurgical thyroid remnant ablation with 131I is considered standard clinical care for most cases of papillary and follicular thyroid cancer to eliminate normal thyroid tissue which may contain microscopic cancer Furthermore ablation enhances the sensitivity of subsequent 131I scanning and serum thyroglobulin TG measurement for the detection of recurrent or persistent disease Low dose 131I 30 mCi successfully ablates thyroid remnant in 8-61 of cases This dose can be repeated and result in overall less radiation exposure than that associated with high dose therapy 100 mCi Ablation achieved with one or more small doses of radioactive iodine is not associated with decreased survival or cancer recurrence According to the literature there is no difference in the 30-year recurrence rates between groups receiving low and high dose ablation therapy for well differentiated thyroid cancer without distant metastases at the time of initial therapy The benefits of using low dose of 131I are minimization of whole body radiation exposure reduction in side effects and lower cost Higher rates of successful ablation by low dose of 131I could be achieved by increasing uptake of 131I andor lengthening retention of radioiodine in the remnant thyroid tissue Recombinant human thyroid-stimulating hormone rhTSH has been used successfully to increase radioiodine uptake Lithium has been used to increase radioiodine retention and has been shown to be useful in the treatment of residual or metastatic cancer The combination of rhTSH and lithium as adjuncts to 30 mCi radioactive iodine RAI ablation therapy in low risk thyroid cancer patients may provide a method that reduces the cumulative dose of radioiodine needed to successfully treat thyroid cancer The specific aim of this study is to determine whether adjunct lithium carbonate improves the success rate of postsurgical ablation of thyroid remnants using low dose 131I 30 mCi and rhTSH in low risk patients with differentiated thyroid carcinoma Patients with well-differentiated papillary or follicular thyroid cancer stage I or II according to the National Thyroid Cancer Treatment Cooperative Study NTCTCS classification at time of surgery will be enrolled Eligible patients will have had a total or near-total thyroidectomy within 6 months of enrollment This randomized placebocontrolled double-blind study will permit an evaluation of the riskbenefit ratio of adding lithium as an adjuvant to the already established method of administering low-dose 131I ablation therapy to optimize the 131I retention All patients will undergo diagnostic rhTSH 123I whole body scan at the end of the study to assess the success of thyroid ablation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 06-DK-0025 | OTHER | NIH Clinical Center | None |