Clinical Trial: Three-Year Follow-up of Radioiodine Therapy for Goitre

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Long-Term Follow-up and Outcome of Administering Recombinant Human Thyrotropin as an Adjuvant of Therapy With Radioiodine in the Outpatient Treatment of Multinodular Goitres

Brief Summary:

Background: Preadministration of recombinant human thyrotropin (rhTSH) increases the amount and homogeneity of thyroid radioiodine uptake, and when used as an adjuvant can augment the efficiency of 131I therapy by allowing multinodular goitre (MNG) volume reduction.

Objective: The investigators aimed to assess low-dose rhTSH-aided fixed-activity radioiodine therapy outcome in MNG patients.

Design: This was a long-term (36 months) observational study. Methods: The investigators measured 24 h thyroid radioiodine uptake (RAIU) of 1.4 µCi (0.5 MBq) of 131-iodine at baseline and 24 h after intramuscular injection of 0.1 mg rhTSH in 42 patients (aged 42-80 years) who subsequently received 30 mCi 131-iodine 24 h after an identical rhTSH injection. Urinary iodine was measured at baseline and at 3 months after following a low iodine diet. TSH, free thyroxine (FT4), T3 (T3) and thyroglobulin (TG) were measured at baseline, 24 h, 48 h, 72 h, 168 h, one month, 3, 6, 9, 12, 18, 24 and 36 months after therapy. Thyroid volume was assessed by computer tomography at baseline and every 6 months thereafter.

Detailed Summary:
Sponsor: University of Sao Paulo

Current Primary Outcome:

Original Primary Outcome:

Current Secondary Outcome:

Original Secondary Outcome:

Information By: University of Sao Paulo

Dates:
Date Received: July 27, 2007
Date Started: January 2002
Date Completion: December 2006
Last Updated: October 16, 2008
Last Verified: October 2008