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Three-Year Follow-up of Radioiodine Therapy for Goitre

Primary Purpose

Tratment of Multinodular Goitre

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Radioactive iodine
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tratment of Multinodular Goitre focused on measuring multinodular, goitre, recombinant human TSH

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    July 27, 2007
    Last Updated
    October 16, 2008
    Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
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    1. Study Identification

    Unique Protocol Identification Number
    NCT00509483
    Brief Title
    Three-Year Follow-up of Radioiodine Therapy for Goitre
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2008
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2002 (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    December 2006 (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Tratment of Multinodular Goitre
    Keywords
    multinodular, goitre, recombinant human TSH

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    40 (false)

    8. Arms, Groups, and Interventions

    Intervention Type
    Radiation
    Intervention Name(s)
    Radioactive iodine
    Intervention Description
    Radioactive iodine preceded by rhTSH

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    20 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Rossana Romão, MD
    Organizational Affiliation
    University of São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Three-Year Follow-up of Radioiodine Therapy for Goitre

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