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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
Sponsor:
Collaborator:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by:
University of Sao Paulo

Study Description
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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.


Condition or disease Intervention/treatment Phase
Tratment of Multinodular Goitre Radiation: Radioactive iodine Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Enrollment : 40 participants
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

Resource links provided by the National Library of Medicine

Drug Information available for: Iodine
U.S. FDA Resources

Arms and Interventions
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Intervention Details:
    Radiation: Radioactive iodine
    Radioactive iodine preceded by rhTSH

Outcome Measures
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Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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


Sponsors and Collaborators
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
Principal Investigator: Rossana Romão, MD University of São Paulo
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

ClinicalTrials.gov Identifier: NCT00509483     History of Changes
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

Keywords provided by University of Sao Paulo:
multinodular
goitre
recombinant human TSH

Additional relevant MeSH terms:
Goiter
Thyroid Diseases
Endocrine System Diseases