CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 34 enrolled
Drug / intervention
Lithium Carbonate +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00251316
NCT00251316Phase 2Completed

The Effects of Lithium Carbonate on Low Dose Radioiodine Ablation in Early Thyroid Cancer Treatment

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)·interventional·Posted Nov 9, 2005·Updated Feb 4, 2013

In Brief

A Phase 2 clinical trial evaluating Lithium Carbonate and Placebo for Thyroid Cancer and Differentiated Thyroid Carcinoma. Completed, enrolled 34 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
2006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedNov 9, 2005
Enrollment StartNov 1, 2005
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 6.1 yearsPosted 20.6 years ago

Interventions

Lithium Carbonatedrug

30 mCi of 131I

Placebodrug

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).