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:

Drug Information available for: Iodine

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:

Radioactive iodine preceded by rhTSH

Eligibility


Ages Eligible for Study:	20 Years and older (Adult, Senior)
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

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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


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

ClinicalTrials.gov processed this record on September 26, 2016

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