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Effect of Lithium Carbonate on Low-Dose Radioiodine Therapy in Early Thyroid Cancer

NCT00251316 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2013-02-04

Study results available
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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.

Conditions

Interventions

DRUG

Lithium Carbonate

30 mCi of 131I

DRUG

Placebo

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).

Sponsors & Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

    lead NIH

Principal Investigators

  • Monica C Skarulis, M.D. · National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-11-30
Primary Completion
2011-12-31
Completion
2011-12-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00251316 on ClinicalTrials.gov