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
About this trial
This is an interventional treatment trial for Tratment of Multinodular Goitre focused on measuring multinodular, goitre, recombinant human TSH
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.
Sites / Locations
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00509483
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
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
We'll reach out to this number within 24 hrs