Comparison of the Safety and Successful Ablation of Thyroid Remnant in Post-thyroidectomized Euthyroid Patients (i.e. Patients Administered Thyrogen) Versus Hypothyroid Patients (no Thyrogen) Following 131I Administration
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
|Official Title:||A Randomized, Controlled, Open-Label, Multi-National Pilot Study of Thyroid Remnant Ablation Comparing the Safety and Ablation Rate Following 131I Administration Using Thyrogen® Versus the Safety and Ablation Rate Following 131I Administration in the Hypothyroid State|
- Use of Thyrogen in euthyroid patients undergoing radioiodine remnant ablation with 100 mCi (3.7 GBq) 131I results in a comparable ablation rate to patients undergoing radioiodine remnant ablation in the hypothyroid state with 100 mCi (3.7 GBq) 131I
- Safety profile of Thyrogen when used for radioiodine remnant ablation
- QoL in patients treated using Thyrogen
- Compare the radioiodine uptake and retention into the thyroid bed in euthyroid patients using Thyrogen and patients treated in the hypothyroid state.
|Study Start Date:||December 2001|
|Estimated Study Completion Date:||September 2003|
Following a total/near-total thyroidectomy, eligible patients provided written informed consent within 14 days post-surgery. Patients were then randomized to 1 of 2 groups: the Euthyroid or the Hypothyroid group.
Once randomized, patients in the Euthyroid group received thyroid hormone suppression therapy (THST) for 4 weeks. At the end of the fourth week, the patient's TSH level was measured. If the TSH level was < 5 mU/L, Thyrogen (0.9 mg) was administered intramuscularly (IM) once daily (qd) for 2 days. Twenty-four hours following the second dose of Thyrogen, an ablative activity of 131I (100 mCi; 3.7 GBq) was administered. All patients then underwent post-treatment whole-body scanning (WBS) and remnant-neck imaging at 48 hours, at 72 to 96 hours, and at 96 to 168 hours (preferably 120 hours) following ablation. In addition, the study allowed for the option to perform scans at 24 hours and between 144 and 168 hours after ablation. Following the final post-treatment scan, patients in the Euthyroid group continued THST.
Patients randomized to the Hypothyroid Group did not receive THST after randomization. These individuals were monitored for at least 4 weeks or until their TSH was > 25 mU/L. Patients were given an ablative dose of 131I (100 mCi, 3.7 GBq). If the patient's TSH was < 25 mU/L at the end of the fourth week, the patient's TSH was measured again 1 week later. Patients then underwent post-treatment WBS and remnant-neck imaging at 48 hours, at 72 to 96 hours, and at 96 to 168 hours (preferably 120 hours) following ablation. In addition, the study allowed for the option to perform scans at 24 hours and between 144 and 168 hours post ablation. Following the final post-treatment scan, patients in the Hypothyroid group commenced THST.
Eight (± l) months later, patients in both the Euthyroid and Hypothyroid groups received Thyrogen (0.9 mg qd for 2 days) followed by an activity of 131I (4 mCi; 0.15 GBq), in preparation for 48-hour WBS and remnant-neck imaging.
Patients with a negative neck scan (i.e. no visible uptake or, if visible uptake, less than 0.1% uptake in the thyroid bed) 8 (+ 1) months following the 131I treatment were considered successfully ablated.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00196729
|Study Director:||Medical Monitor||Genzyme, a Sanofi Company|