Three-Year Follow-up of Radioiodine Therapy for Goitre
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ClinicalTrials.gov Identifier: NCT00509483 |
Recruitment Status :
Completed
First Posted : July 31, 2007
Last Update Posted : October 17, 2008
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Tratment of Multinodular Goitre | Radiation: Radioactive iodine | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Enrollment : | 40 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | January 2002 |
Study Completion Date : | December 2006 |
- Radiation: Radioactive iodine
Radioactive iodine preceded by rhTSH

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Ages Eligible for Study: | 20 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00509483
Principal Investigator: | Rossana Romão, MD | University of São Paulo |
ClinicalTrials.gov Identifier: | NCT00509483 |
Other Study ID Numbers: |
PRN 833/02 |
First Posted: | July 31, 2007 Key Record Dates |
Last Update Posted: | October 17, 2008 |
Last Verified: | October 2008 |
multinodular goitre recombinant human TSH |
Goiter Thyroid Diseases Endocrine System Diseases |