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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


Phase 3
20 Years
68 Years
Not Enrolling
Both
Thyroid Neoplasms

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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.


Inclusion Criteria:



- Patients who were at least 18 years old (male or female).

- Patients with newly diagnosed differentiated papillary or follicular thyroid
carcinoma, including papillary-follicular variant, characterized as "T2, N0 or N1,
and M0" or as "T1, N1, and M0".

- Patients with a total or near-total thyroidectomy within 2 weeks prior to enrollment.

Exclusion Criteria:

- see above

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

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

Principal Investigator

Medical Monitor

Investigator Role:

Study Director

Investigator Affiliation:

Genzyme

Authority:

United States: Food and Drug Administration

Study ID:

THYR00800

NCT ID:

NCT00196729

Start Date:

December 2001

Completion Date:

September 2003

Related Keywords:

  • Thyroid Neoplasms
  • Neoplasms
  • Thyroid Neoplasms
  • Hypothyroidism
  • Thyroid Diseases

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