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

Phase 2
16 Years
Not Enrolling
Thyroid Cancer, Differentiated Thyroid Carcinoma

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Trial Information

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

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.

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

2. Patients younger than 45 years with any size of primary papillary or follicular

3. Patients older than 45 years with:

1. primary papillary tumor less than 4 cm or

2. primary follicular tumor less than 1 cm


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,

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Outcome Measure:

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

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Monica C Skarulis, M.D.

Investigator Role:

Principal Investigator

Investigator Affiliation:

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


United States: Federal Government

Study ID:




Start Date:

November 2005

Completion Date:

December 2011

Related Keywords:

  • Thyroid Cancer
  • Differentiated Thyroid Carcinoma
  • Thyroid Neoplasm
  • I-131
  • Radiation Dose
  • Radiation Effect
  • Pharmaceutical Adjuvant
  • Thyroid Cancer
  • Carcinoma
  • Thyroid Neoplasms
  • Thyroid Diseases



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