A Dosimetry Study of Radioiodine (131-I) Uptake Following the Administration of Thyrogen and Hypothyroid States During Thyroid Hormone Withdrawal
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.
Interventional
Primary Purpose: Treatment
United States: Federal Government
980038
NCT00001730
December 1997
April 2000
Name | Location |
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Bethesda, Maryland 20892 |