Tratment of Multinodular Goitre Clinical Trial
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
| Verified date | October 2008 |
| Source | University of Sao Paulo |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Brazil: National Committee of Ethics in Research |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 40 |
| Est. completion date | December 2006 |
| Est. primary completion date | |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 20 Years and older |
| Eligibility |
Inclusion Criteria: - Patients with multinodular goitre Exclusion Criteria: - Aversion to any form of treatment - Previous radioiodine therapy - Being unable to complete a prolonged follow-up; and - Having serious cardiovascular disorders. |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| University of Sao Paulo | Fundação de Amparo à Pesquisa do Estado de São Paulo |