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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
History of Changes
  Purpose

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 Intervention
Tratment of Multinodular Goitre
 Radiation: Radioactive iodine

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Thyroid Diseases
Drug Information available for: Iodine Iodide
U.S. FDA Resources

Further study details as provided by University of Sao Paulo:

Estimated Enrollment: 40
Study Start Date: January 2002
Estimated Study Completion Date: December 2006
Intervention Details:
    Radiation: Radioactive iodine
    Radioactive iodine preceded by rhTSH
  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

ClinicalTrials.gov Identifier: NCT00509483     History of Changes
Other Study ID Numbers: PRN 833/02
Study First Received: July 27, 2007
Last Updated: October 16, 2008
Health Authority: Brazil: National Committee of Ethics in Research

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

Additional relevant MeSH terms:
Goiter
Thyroid Diseases
Endocrine System Diseases
Iodine
Anti-Infective Agents, Local
Anti-Infective Agents
 Therapeutic Uses
Pharmacologic Actions
Trace Elements
Micronutrients
Growth Substances
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on May 16, 2013