NCT01204359

The Prospective Study of Standard Treatment of Graves Disease Iodine 131 and Prevention of Adverse Reactions

"5010 Clinical Research Programme"of Sun Yat-sen University

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 627 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 8 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

Iodine 131 (131I） treatment on Graves disease and Graves ophthalmopathy relationship has always been the focus of debate. Majority view is that the current treatment does not increase 131I Graves ophthalmopathy, therefore,Graves disease associated with exophthalmos is not a contraindication of 131I treatment. While treatment with corticosteroids, a timely corrective measures to be effective in preventing Graves ophthalmopathy adverse effects. But the merger with severe proptosis in patients with Graves , especially infiltrative exophthalmos , the application of 131I treatment will induce or aggravate not yet reached consensus, so, the 131I treatment is still very careful , mainly due to plaque prospective study and visual assessment is not lack of uniform standards, and a variety of factors (including smoking, work status, and 131I treatment of thyroid doses, etc.) may also interfere or influence the ultimate effect of 131I on the Graves ophthalmopathy. In the view of this situation Graves disease patients with Graves ophthalmopathy could be 131I treatment or not, how to dose adjustments, and the use of which required treatment with systemic issues such as research, explore treatment exophthalmos reduction and mitigation of increased proptosis reasonable treatment of symptoms. To further promote the standardization of 131I treatment of Graves disease on basis.

Detailed description

no more description

Conditions

• Hypothyroidism
• Exophthalmos

Interventions

Type	Name	Description
RADIATION	Iodine 131	iodine 131，185、370、555mBq，6 months

Timeline

• Start date: 2007-07-01
• Primary completion: 2016-07-01
• Completion: 2016-12-01
• First posted: 2010-09-17
• Last updated: 2015-05-25

Locations

2 sites across 1 country: China