Study of Radioiodine (131-I) Uptake Following Administration of Thyrogen and Hypothyroid States During Thyroid Hormone Withdrawal.
Summary
Thyroid cancer is typically treated with surgery, radiation or a combination of both. Following surgical removal of thyroid tissue patients receive thyroid hormone replacement medication. In addition patients undergo tests to determine the status of the disease. One of the tests conducted is a whole body scan using radioactive iodine to detect and locate any remaining cancerous thyroid tissue.
Thyroid tissue uses iodine to make thyroid hormones (T3 and T4). In order for a radioiodine scan to work, cancerous thyroid tissue must be "hungry" for iodine. Thyroid stimulating hormone (TSH) produced in the pituitary gland is responsible for making thyroid tissue "hungry" for iodine. Once thyroid tissue absorbs the radioactive iodine it will be clearly visible on the scan and can be located for removal. However, thyroid hormone replacement medication tends to lower the activity of the pituitary gland and the amount of naturally produced TSH. So it is necessary to stop thyroid hormone replacement to increase TSH. A problem arises when there is a lack of thyroid hormone replacement causing patients to experience hypothyroidism. This condition is associated with unpleasant physical and emotional symptoms.
TSH has been created in a laboratory and called Thyrogen. It is basically the same as the TSH produced in the human pituitary gland. However, Thyrogen increases the level of TSH in the body without having to stop thyroid replacement medication. Therefore patients will not experience hypothyroidism while preparing for a radioactive iodine scan.
The objective of this study is to compare the activity of radioiodine (131I) in patients taking Thyrogen with normal thyroid activity versus patients with hypothyroid activity after thyroid replacement medication is withdrawn. In addition the study will provide information on how radioactive iodine is eliminated from the body. The study will help researchers understand how to give Thyrogen and radioiodine for purposes of scanning and therapeutic ablation (the destruction of function) of cancerous thyroid tissue.
The study will accept patients with non-medullary thyroid cancer who are preparing for ablation therapy. The patients will be placed in one of two groups. Group one will receive Thyrogen in 2 doses 24 hours apart. Group two will receive Thyrogen in 3 doses 72 hours apart. The patients will undergo two 131I whole body scans: one after Thyrogen while taking thyroid hormone suppressive and the second after withdrawal from thyroid hormone. 131I ablative therapy will be given under hypothyroid conditions at the completion of the study.
Description
This is a multi-centered, open-labeled, randomized, two parallel-arm study designed to compare quantitative radiation dosimetry assessments obtained during thyroid hormone suppression therapy with recombinant human TSH (Thyrogen® (Registered Trademark)) and hypothyroidism in thyroid cancer patients preparing for post-surgical radioiodine ablation. The primary endpoint of this study is to identify the ratio of administered activity of radioiodine (131I) to deliver a targeted dose of 30,000 rad to the thyroid remnant when patients are euthyroid on Thyrogen® (Registered Trademark) and hypothyroid after hormone withdrawal. Secondary endpoints are to identify and compare effective 131I clearance and cumulated activity in the whole body and blood during euthyroid and hypothyroid states.
All adult patients with differentiated non-medullary thyroid cancer who are preparing for ablation therapy are eligible for participation. Patients will be randomized to one of two different dosing regimens of Thyrogen® (Registered Trademark). Participants will undergo two 131I whole body scans: one after Thyrogen® (Registered Trademark) while taking thyroid hormone suppressive therapy and the second after withdrawal from thyroid hormone. 131I ablative therapy will be given under hypothyroid conditions at the completion of the dosimetry study.
Study Design
Primary Purpose: Treatment
Conditions
Hypothyroidism
Intervention
Thyrogen
Location
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda
Maryland
United States
20892
Status
Completed
Source
National Institutes of Health Clinical Center (CC)
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00001730
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Congenital Hypothyroidism
A condition in infancy or early childhood due to an in-utero deficiency of THYROID HORMONES that can be caused by genetic or environmental factors, such as thyroid dysgenesis or HYPOTHYROIDISM in infants of mothers treated with THIOURACIL during pregnancy. Endemic cretinism is the result of iodine deficiency. Clinical symptoms include severe MENTAL RETARDATION, impaired skeletal development, short stature, and MYXEDEMA.
Hashimoto Disease
Chronic autoimmune thyroiditis, characterized by the presence of high serum thyroid AUTOANTIBODIES; GOITER; and HYPOTHYROIDISM.
Hypothyroidism
A syndrome that results from abnormally low secretion of THYROID HORMONES from the THYROID GLAND, leading to a decrease in BASAL METABOLIC RATE. In its most severe form, there is accumulation of MUCOPOLYSACCHARIDES in the SKIN and EDEMA, known as MYXEDEMA.
Lingual Goiter
Pathological enlargement of the LINGUAL THYROID, ectopic thyroid tissue at the base of the TONGUE. It may cause upper AIRWAY OBSTRUCTION; DYSPHAGIA; or HYPOTHYROIDISM symptoms.
Thyroid Dysgenesis
Defective development of the THYROID GLAND. This concept includes thyroid agenesis (aplasia), hypoplasia, or an ectopic gland. Clinical signs usually are those of CONGENITAL HYPOTHYROIDISM.
Clinical Trials
Quality of Life, Recombinant TSH (Thyrogen) and Thyroid Cancer
To evaluate quality of life in patients after 10 days pause of thyroid medication (Liothyronine) compared to treatment with recombinant TSH (Thyrogen) before radioiodine uptake and treatm...
Lipids Profile in Subclinical Hypothyroidism
Overt hypothyroidism is associated with increased risk for cardiovascular disease (CVD) as indicated by hypertension, hypercholesterolemia, and increased low-density lipoprotein cholestero...
Insulin Sensitivity and Metabolism Before and After Treatment in Patients With Hypothyroidism
The aim of this study is to further characterize the treatment related changes in insulin sensitivity, substrate metabolism and intra hepatic- and intramyocellular lipid content in patient...
This study was conducted in patients with differentiated thyroid cancer who had undergone near-total thyroidectomy. After surgery patients were randomized to one of two methods of perform...
Measurement of Hormonal Concentration in Chylothorax Fluid in Infants With Congenital Chylothorax
Late onset Hypothyroidism was found in infant with congenital hypothyroidism. The hypothesis is that infants with congenital hypothyroidism may lose thyroxin and other hormones via the chy...
PubMed Articles
A novel mutation in thyrotropin (thyroid-stimulating hormone) gene in congenital hypothyroidism.
Abstract A 3-year-old girl had global developmental delay with dysmorphic facies. In addition, she was found to have congenital hypothyroidism. In view of the associated dysmorphism, a karyotype analy...
Subclinical Hypothyroidism in the Elderly: To Treat or Not to Treat?
Aging is associated with a host of alterations in thyroid gland structure and function. Some of these changes have favorable effects on longevity, whereas others are maladaptive and contribute to a de...
Hypothyroidism in Children Beyond 5 y of Age: Delayed Diagnosis of Congenital Hypothyroidism.
OBJECTIVE: To determine the frequency of undiagnosed congenital hypothyroidism (CH) and its manifestations in hypothyroid children presenting beyond 5 y of age....
Prevalence of Hypothyroidism in Nonalcoholic Fatty Liver Disease.
BACKGROUND: A possible association between nonalcoholic fatty liver disease (NAFLD) and hypothyroidism has been suggested. The recognized link between hypothyroidism and elements...
Congenital von Willebrand's disease and clinical hypothyroidism.
Data from case reports and systematic reviews suggest an association of Hypothyroidism and Acquired von Willebrand's syndrome. It is not known if congenital von Willebrand's disease is associated with...
