Comparison of Different Doses of 131I in Severe Graves' Hyperthyroidism

This study has been completed.
Sponsor:
Collaborator:
Federal University of Rio Grande do Sul
Information provided by (Responsible Party):
Ana Luiza Maia, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier:
NCT01039818
First received: December 24, 2009
Last updated: September 4, 2012
Last verified: September 2012
  Purpose

The purpose of this study is to determine whether higher doses of radioiodine increase treatment efficacy in severe Graves' disease.


Condition Intervention Phase
Graves Disease
Radiation: Radioiodine
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparison of Different Doses of 131I in Severe Graves' Hyperthyroidism: A Clinical Trial With Historical Control

Resource links provided by NLM:


Further study details as provided by Hospital de Clinicas de Porto Alegre:

Primary Outcome Measures:
  • Cure, defined as euthyroidism or permanent hypothyroidism based on FT4 measurements. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Euthyroidism [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Permanent hypothyroidism [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: February 1997
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Radiodine-200µCi
A subgroup of patients with Graves' Disease and goiter ≥48ml treated with 200µCi of ¹³¹I/ml thyroid tissue, corrected by 24h-RAIU, from a randomized controlled trial run at our institution between February 1997 and March 2000, serves as a historical control.
Radiation: Radioiodine
A unique dose of 200µCi of ¹³¹I/ml/24-RAIU
Experimental: Radiodine-250µCi
Patients with Graves' Disease and goiter ≥48ml, prospectively assigned to receive 250 µCi of ¹³¹I/ml thyroid tissue, corrected by 24h-RAIU.
Radiation: Radioiodine
A unique dose of 250µCi of ¹³¹I/ml/24-RAIU

Detailed Description:

Graves' disease (GD) is the most frequent cause of hyperthyroidism, affecting mainly women aged 40-60 years. Radioiodine (¹³¹I), introduced in 1941, has become a cornerstone in the treatment of GD hyperthyroidism. Because of its safety, low costs and rapid effect, it is considered a first line therapy in the United States. However, treatment failure occurs in about 15-25% of patients treated with radioiodine. Patients not cured with the first dose of radioiodine usually present severe hyperthyroidism, characterized by large goiter, high 24-hour radioiodine uptake (24h-RAIU) and very high levels of thyroid hormones. We have previously shown that large goiter (≥48ml) is an independent predictor of treatment failure. In these patients, the therapeutic failure was 40.0% while in patients with smaller goiter was only 6.5% (P=0.005; unpublished). It is generally accepted that higher doses of radioiodine improves cure rates. Indeed, a recent meta-analysis found a correlation between radioiodine dose and therapeutic success in GD patients. To our knowledge, there are no published studies evaluating cure rates with different radioiodine doses in severe GD.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Consecutive patients with a recent diagnosis of Graves' disease and goiter ≥ 48 ml, attending the Endocrine Division at Hospital de Clinicas de Porto Alegre are eligible.

Exclusion Criteria:

  • Patients with previous treatment with radioiodine or thyroidectomy,
  • Signs of moderate or severe ophthalmopathy (proptosis > 22 mm, ophthalmoplegia, chemosis, or lagophthalmos),
  • Severe heart disease (symptomatic coronary heart disease, class III heart failure, New York Heart Association criteria),
  • Debilitating conditions, and
  • Large and compressive goiters (> 150 g).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01039818

Locations
Brazil
Thyroid Unit, Endocrine Division, Hospital de Clínicas de Porto Alegre
Porto Alegre, RS, Brazil, 90035-003
Sponsors and Collaborators
Hospital de Clinicas de Porto Alegre
Federal University of Rio Grande do Sul
Investigators
Principal Investigator: Ana L Maia, MD, PhD Thyroid Unit, Endocrine Division, Hospital de Clínicas de Porto Alegre
  More Information

Publications:
Responsible Party: Ana Luiza Maia, PhD, Hospital de Clinicas de Porto Alegre
ClinicalTrials.gov Identifier: NCT01039818     History of Changes
Other Study ID Numbers: 07-055
Study First Received: December 24, 2009
Last Updated: September 4, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital de Clinicas de Porto Alegre:
Graves Disease
Hyperthyroidism
Radioiodine
Clinical trial

Additional relevant MeSH terms:
Graves Disease
Hyperthyroidism
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on April 15, 2014