Status:

COMPLETED

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

Lead Sponsor:

Genzyme, a Sanofi Company

Conditions:

Thyroid Neoplasms

Eligibility:

All Genders

20-68 years

Phase:

PHASE3

Brief Summary

This study was conducted in patients with differentiated thyroid cancer who had undergone near-total thyroidectomy. After surgery patients were randomized to one of two methods of performing thyroid r...

Detailed Description

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 Hypoth...

Eligibility Criteria

Inclusion

  • 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

  • see above

Key Trial Info

Start Date :

December 1 2001

Trial Type :

INTERVENTIONAL

End Date :

September 1 2003

Estimated Enrollment :

63 Patients enrolled

Trial Details

Trial ID

NCT00196729

Start Date

December 1 2001

End Date

September 1 2003

Last Update

March 18 2015

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