Comparison of Different Doses of 131I in Severe Graves' Hyperthyroidism
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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 |
- Cure, defined as euthyroidism or permanent hypothyroidism based on FT4 measurements. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- 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 |
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| Brazil | |
| Thyroid Unit, Endocrine Division, Hospital de Clínicas de Porto Alegre | |
| Porto Alegre, RS, Brazil, 90035-003 | |
| 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 May 19, 2013