Comparison of Different Doses of 131I in Severe Graves' Hyperthyroidism
Primary Purpose
Graves Disease
Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Radioiodine
Radioiodine
Sponsored by
About this trial
This is an interventional treatment trial for Graves Disease focused on measuring Graves Disease, Hyperthyroidism, Radioiodine, Clinical trial
Eligibility 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).
Sites / Locations
- Thyroid Unit, Endocrine Division, Hospital de Clínicas de Porto Alegre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Radiodine-200µCi
Radiodine-250µCi
Arm Description
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.
Patients with Graves' Disease and goiter ≥48ml, prospectively assigned to receive 250 µCi of ¹³¹I/ml thyroid tissue, corrected by 24h-RAIU.
Outcomes
Primary Outcome Measures
Cure, defined as euthyroidism or permanent hypothyroidism based on FT4 measurements.
Secondary Outcome Measures
Euthyroidism
Permanent hypothyroidism
Full Information
NCT ID
NCT01039818
First Posted
December 24, 2009
Last Updated
September 4, 2012
Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
1. Study Identification
Unique Protocol Identification Number
NCT01039818
Brief Title
Comparison of Different Doses of 131I in Severe Graves' Hyperthyroidism
Official Title
Comparison of Different Doses of 131I in Severe Graves' Hyperthyroidism: A Clinical Trial With Historical Control
Study Type
Interventional
2. Study Status
Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
February 1997 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital de Clinicas de Porto Alegre
Collaborators
Federal University of Rio Grande do Sul
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine whether higher doses of radioiodine increase treatment efficacy in severe Graves' disease.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Graves Disease
Keywords
Graves Disease, Hyperthyroidism, Radioiodine, Clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Radiodine-200µCi
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Radiodine-250µCi
Arm Type
Experimental
Arm Description
Patients with Graves' Disease and goiter ≥48ml, prospectively assigned to receive 250 µCi of ¹³¹I/ml thyroid tissue, corrected by 24h-RAIU.
Intervention Type
Radiation
Intervention Name(s)
Radioiodine
Intervention Description
A unique dose of 200µCi of ¹³¹I/ml/24-RAIU
Intervention Type
Radiation
Intervention Name(s)
Radioiodine
Intervention Description
A unique dose of 250µCi of ¹³¹I/ml/24-RAIU
Primary Outcome Measure Information:
Title
Cure, defined as euthyroidism or permanent hypothyroidism based on FT4 measurements.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Euthyroidism
Time Frame
12 months
Title
Permanent hypothyroidism
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ana L Maia, MD, PhD
Organizational Affiliation
Thyroid Unit, Endocrine Division, Hospital de Clínicas de Porto Alegre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Thyroid Unit, Endocrine Division, Hospital de Clínicas de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90035-003
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
10566642
Citation
Andrade VA, Gross JL, Maia AL. Effect of methimazole pretreatment on serum thyroid hormone levels after radioactive treatment in Graves' hyperthyroidism. J Clin Endocrinol Metab. 1999 Nov;84(11):4012-6. doi: 10.1210/jcem.84.11.6149.
Results Reference
background
PubMed Identifier
11502768
Citation
Andrade VA, Gross JL, Maia AL. The effect of methimazole pretreatment on the efficacy of radioactive iodine therapy in Graves' hyperthyroidism: one-year follow-up of a prospective, randomized study. J Clin Endocrinol Metab. 2001 Aug;86(8):3488-93. doi: 10.1210/jcem.86.8.7707.
Results Reference
background
PubMed Identifier
15476447
Citation
Andrade VA, Gross JL, Maia AL. Serum thyrotropin-receptor autoantibodies levels after I therapy in Graves' patients: effect of pretreatment with methimazole evaluated by a prospective, randomized study. Eur J Endocrinol. 2004 Oct;151(4):467-74. doi: 10.1530/eje.0.1510467.
Results Reference
background
PubMed Identifier
15611828
Citation
Andrade VA, Gross JL, Maia AL. [Radioactive iodine therapy in Graves' hyperthyroidism]. Arq Bras Endocrinol Metabol. 2004 Feb;48(1):159-65. doi: 10.1590/s0004-27302004000100017. Epub 2004 Jun 1. Portuguese.
Results Reference
background
PubMed Identifier
23984185
Citation
Dora JM, Escouto Machado W, Andrade VA, Scheffel RS, Maia AL. Increasing the radioiodine dose does not improve cure rates in severe graves' hyperthyroidism: a clinical trial with historical control. J Thyroid Res. 2013;2013:958276. doi: 10.1155/2013/958276. Epub 2013 Jul 31.
Results Reference
derived
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Comparison of Different Doses of 131I in Severe Graves' Hyperthyroidism
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