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

5010 Clinical Research Programmeof Sun Yat-sen University

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01204359
Enrollment
627
Registered
2010-09-17
Start date
2007-07-31
Completion date
2016-12-31
Last updated
2015-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exophthalmos, Hypothyroidism

Brief 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

Interventions

RADIATIONIodine 131

iodine 131,185、370、555mBq,6 months

Sponsors

Sun Yat-sen University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Caregiver, Investigator)

Eligibility

Sex/Gender
ALL
Age
8 Years to 90 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
The rate of Hypothyroidism after Iodine 131 treatmentone year

Secondary

MeasureTime frame
The side effect to Infiltrative exophthalmos after Iodine 131 treatmentone year

Countries

China

Contacts

Primary Contactningyi jiang, bachelor
ningyij@163.net+8613602753179

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026