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

Hypothyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01204359
• Other study ID #: 2007022
• Status: Recruiting
• Phase: Phase 3
• First received: September 15, 2010
• Last updated: May 22, 2015
• Start date: July 2007
• Est. completion date: December 2016

Study information

• Verified date: May 2015
• Source: Sun Yat-sen University
• Contact: ningyi jiang, bachelor
• Phone: +8613602753179
• Email: ningyij[@]163.net
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Description:

no more description

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 627
• Est. completion date: December 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 8 Years to 90 Years

Eligibility

Inclusion Criteria:

• a typical clinical symptoms of Graves disease, diffuse goiter, eye signs (including exophthalmos), thyroid function (FT3, FT4, rTSH) and thyroid autoantibodies and imaging examinations to confirmed.

Exclusion Criteria:

• 131I treatment contraindications, those who have not signed the informed consent, failure to complete treatment and follow-up estimates of patients and patients not suitable for radionuclide therapy

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Caregiver, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Exophthalmos
• Hypothyroidism

Intervention

Radiation:
• Iodine 131
iodine 131,185?370?555mBq,6 months

Locations

Country	Name	City	State
China	Ningyi Jiang	Guangzhou
China	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of Hypothyroidism after Iodine 131 treatment		one year	Yes
Secondary	The side effect to Infiltrative exophthalmos after Iodine 131 treatment		one year	Yes