Trial Information

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

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.