Protocol Number: 06-DK-0025

Title:

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

Number:

06-DK-0025

Summary:

This study will determine if lithium can enhance the treatment effect of low-dose of 131I (radioactive iodine) following surgery in patients with thyroid cancer. 131I is used to destroy any thyroid tissue remaining after surgery. This is called ablation therapy. Doctors often use a high dose of the 131I (100 to 150 millicuries, or mCi) to ensure successful ablation. A lower dose, however, would minimize excess radiation exposure and possible side effects of the 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.

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. Candidates are screened with a medical history, physical examination, blood tests, thyroid ultrasound and chest x-ray.

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.

On day 2 of hospitalization, patients have a whole-body scan to determine how much functional thyroid remained after surgery and to rule out spread of the cancer. For 2 days before the scan, they receive an injection of recombinant thyroid stimulating hormone (TSH), a laboratory-made drug that is almost identical to the TSH normally made by the pituitary gland. Then they swallow a capsule containing a small amount of 131I, which is used for imaging the thyroid. A special camera takes pictures of the neck after 4 hours and after 24 hours. TSH injections are repeated for 2 more days to prepare for therapy with 131I. On about day 7 of hospitalization, patients take a capsule containing low-dose 131I. Each remaining day in the hospital, patients have additional blood tests to measure the level of radioactivity and scans to evaluate the effectiveness of lithium or placebo and low-dose 131I for ablation. On the last day in the hospital, patients stop taking lithium or placebo and have a repeat scan to make sure that the cancer has not spread outside the thyroid gland.

After discharge from the hospital, patients have the following procedures:

-After 3 to 6 months: Questionnaire about their health

-After 6 months: Physical examination and blood tests

-After 1 year: Repeat scan and blood tests after eating a low-iodine diet for 2 weeks and receiving two recombinant TSH injections

Sponsoring Institute:

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

Recruitment Detail

Type: Participants currently recruited/enrolled

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): None

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)

Patients with known allergy to lithium salts, bovine or human TSH or anaphylactic response to iodine containing foods (shellfish) or products.

Patients who had administration of radiocontrast material for imaging studies within the last 6 months.

Special Instructions:

Currently Not Provided

Keywords:

Thyroid Neoplasm

I-131

Radiation Dose

Radiation Effect

Pharmaceutical Adjuvant

Recruitment Keyword(s):

Thyroid Cancer

Condition(s):

Thyroid Cancer

Differentiated Thyroid Carcinoma

Investigational Drug(s):

None

Investigational Device(s):

None

Intervention(s):

Drug: Lithium Carbonate

Supporting Site:

National Institute of Diabetes and Digestive and Kidney Disorders

Contact(s):

Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local),1-866-411-1010 (toll free)
Fax: 301-480-9793

Electronic Mail:prpl@mail.cc.nih.gov

Citation(s):

Sherman SI. Thyroid carcinoma. Lancet. 2003 Feb 8;361(9356):501-11. Review.

Mazzaferri EL. An overview of the management of papillary and follicular thyroid carcinoma. Thyroid. 1999 May;9(5):421-7. Review.

Mazzaferri EL, Jhiang SM. Long-term impact of initial surgical and medical therapy on papillary and follicular thyroid cancer. Am J Med. 1994 Nov;97(5):418-28. Erratum in: Am J Med 1995 Feb;98(2):215.

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