Three-Year Follow-up of Radioiodine Therapy for Goitre

This study has been completed.
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT00509483
First received: July 27, 2007
Last updated: October 16, 2008
Last verified: October 2008

July 27, 2007
October 16, 2008
January 2002
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Complete list of historical versions of study NCT00509483 on ClinicalTrials.gov Archive Site
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Three-Year Follow-up of Radioiodine Therapy for Goitre
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

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.

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Interventional
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Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Tratment of Multinodular Goitre
Radiation: Radioactive iodine
Radioactive iodine preceded by rhTSH
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
December 2006
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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.
Both
20 Years and older
No
Contact information is only displayed when the study is recruiting subjects
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NCT00509483
PRN 833/02
No
Not Provided
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Principal Investigator: Rossana Romão, MD University of São Paulo
University of Sao Paulo
October 2008

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP