Phase 2
N=34
Effect of Lithium Carbonate on Low-Dose Radioiodine Therapy in Early Thyroid Cancer
Thyroid Cancer · Differentiated Thyroid Carcinoma
Bottom Line
View on ClinicalTrials.gov: NCT00251316 ↗Enrolled (actual)
34
Serious AEs
3.5%
Results posted
Dec 2012
Primary outcome: 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. — 10; 10 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Lithium Carbonate (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| 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. |
10; 10 | — |
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.
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)
Data sourced from ClinicalTrials.gov (NCT00251316). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.