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...
Date First Received: July 27, 2007
Last Updated: October 16, 2008
Verified by: University of Sao Paulo, October 2008
Clinical Trial Phase: N/A | Start Date: January 2002
Overall Status: Completed
Estimated Enrollment: 40
Brief Summary
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”
Condition Keyword(s):
Intervention(s):
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.
Study Type: Interventional
Study Design: Treatment, Open Label, Single Group Assignment, Efficacy Study
Intervention(s) in this Clinical Trial
- Radiation: Radioactive iodine
- Radioactive iodine preceded by rhTSH
Criteria for Participation in this Clinical Trial
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.
Gender Eligibility for this Clinical Trial: Both
Minimum Age for this Clinical Trial: 20 Years
Maximum Age for this Clinical Trial: N/A
Are Healthy Volunteers Accepted for this Clinical Trial?: No
Clinical Trial Sponsor Information
Lead Sponsor: University of Sao Paulo
Overall Clinical Trial Officials and Contacts
Rossana Romão, MD Principal Investigator University of São Paulo
Additional Information
Information obtained from ClinicalTrials.gov on November 20, 2008
Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00509483
Study ID Number: PRN 833/02
ClinicalTrials.gov Identifier: NCT00509483
Health Authority: Brazil: National Committee of Ethics in Research
Clinical Trials Authorship and Review
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