Study of Radioiodine (131-I) Uptake Following Administration of Thyrogen and Hypothyroid States During Thyroid Hormone Withdrawal.
Study of Radioiodine (131-I) Uptake Following Administration of Thyrogen and Hypothyroid States During Thyroid Hormone Withdrawal.
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 thyroid replacement medication is withdrawn.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.
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.
Patients greater than or equal to 18 years of age, with well-differentiated, non-medullary
 thyroid cancer, including papillary (including follicular-variant), follicular, and Hurthle
 cell.

 Patients who recently have undergone a total or near-total thyroidectomy and are scheduled
 to undergo initial 131I diagnostic studies and ablation.

 Patients must have evidence of residual thyroid tissue after thyroid surgery confirmed by
 ultrasound or other imaging technique (e.g., a technetium [Tc 99] pertechnetate or thallium
 scan).

 Patients who have undergone thyroidectomy or other thyroid surgery at least 6 weeks prior
 to enrollment.

 All patients who have been sustained on maintenance THST for at least 4 weeks, but not
 longer than 12 weeks after thyroidectomy.

 All patients who have confirmed serum TSH levels less than or equal to 0.5 mU per liter
 within 7 days prior to the first Thyrogen dose, and prior to randomization.

 Female patients of childbearing age must have a negative serum human chorionic gonadotropin
 (HCG) pregnancy test prior to entering the study and within 5 days of any 131I
 administration and must be following an approved method of contraception.

 Patients who are committed to following the protocol requirements as evidenced by providing
 written informed consent.

 Patients for whom a 131I scan is currently contraindicated because withdrawal from THST is
 not an option due to pituitary dysfunction or other compelling medical reasons are
 excluded.

 Patients should not have a concurrent major medical disorder (e.g., documented cardiac
 disease, debilitating cardiopulmonary disease, advanced renal failure, advanced liver
 disease or advanced pulmonary disease) who may be too ill to adequately comply with the
 requirements of this study.

 Patients with non-thyroidal conditions known to effect 131I uptake (e.g., congestive heart
 failure, renal failure) are excluded.

 Patients should not have undergone any intravenous water soluble radiographic contrast
 administration within the previous 4 weeks.

 Patients should not have received intrathecal or cholecystographic iodinated contrast agent
 administration within 3 months prior to enrollment.

 Patients should not be taking drugs that affect thyroid or renal function (e.g., renal
 drugs, lithium, or corticosteroids).

 Patients should not be participating in another investigational drug study or in such a
 study within 30 days of their enrollment in this study.

 No patients with a recent history of alcoholism or drug abuse, severe emotional behavioral
 or psychiatric problems who, in the opinion of the investigator, would not be able to
 comply with the requirements of this study.