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| Sponsor: | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00251316 |
Purpose
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:
| Condition | Intervention | Phase |
|---|---|---|
|
Thyroid Cancer Differentiated Thyroid Carcinoma |
Drug: Lithium Carbonate |
Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | The Effects of Lithium Carbonate on Low Dose Radioiodine Ablation in Early Thyroid Cancer Treatment |
| Enrollment: | 34 |
| Study Start Date: | November 2005 |
| Study Completion Date: | December 2011 |
| Primary Completion Date: | December 2011 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 16 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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:
EXCLUSION CRITERIA
Patients with postsurgical thyroid remnant more than 5 g
Patients with distant metastases
Patients above 45 years of age having:
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.
Contacts and Locations More Information
| Responsible Party: | Monica C. Skarulis, M.D./National Institute of Diabetes and Digestive and Kidney Diseases, National Institutes of Health |
| ClinicalTrials.gov Identifier: | NCT00251316 History of Changes |
| Other Study ID Numbers: | 060025, 06-DK-0025 |
| Study First Received: | November 9, 2005 |
| Last Updated: | January 4, 2012 |
| Health Authority: | United States: Federal Government |
|
Thyroid Neoplasm I-131 Radiation Dose |
Radiation Effect Pharmaceutical Adjuvant Thyroid Cancer |
|
Carcinoma Thyroid Neoplasms Thyroid Diseases Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Head and Neck Neoplasms Endocrine System Diseases Lithium Carbonate Lithium |
Antidepressive Agents Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antimanic Agents Tranquilizing Agents Central Nervous System Depressants Physiological Effects of Drugs Antipsychotic Agents |
