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

January 29, 2013 updated by: Monica Skarulis, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Postsurgical thyroid remnant ablation with (131)I 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 (131)I scanning and serum thyroglobulin (TG) measurement for the detection of recurrent or persistent disease. Low dose (131)I (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 (131)I 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 (131)I and/or 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 (131)I (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 risk/benefit ratio of adding lithium as an adjuvant to the already established method of administering low-dose (131)I ablation therapy, to optimize the (131)I retention. All patients will undergo diagnostic rhTSH (123)I whole body scan at the end of the study to assess the success of thyroid ablation.

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center, 9000 Rockville Pike

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

  • 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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lithium Carbonate
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 lithium capsules.
Drug: Lithium Carbonate
30 mCi of 131I
Other Names:
  • Lithium carabonate
Placebo Comparator: 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).
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).
Other Names:
  • Identical placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The Rate of Successful Thyroid Ablation as Defined by Negative Recombinant Human Thyrotropin (rhTSH) Stimulated Radioiodine Whole Body Scan (RAI WBS) at 1 Year.
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2005

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

November 9, 2005

First Submitted That Met QC Criteria

November 8, 2005

First Posted (Estimate)

November 9, 2005

Study Record Updates

Last Update Posted (Estimate)

February 4, 2013

Last Update Submitted That Met QC Criteria

January 29, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 060025
  • 06-DK-0025 (Other Identifier: NIH Clinical Center)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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