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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2010 by Sun Yat-sen University
Sponsor:
Information provided by:
Sun Yat-sen University
ClinicalTrials.gov Identifier:
NCT01204359
First received: September 15, 2010
Last updated: September 27, 2010
Last verified: September 2010

September 15, 2010
September 27, 2010
July 2007
July 2016   (final data collection date for primary outcome measure)
The rate of Hypothyroidism after Iodine 131 treatment [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01204359 on ClinicalTrials.gov Archive Site
The side effect to Infiltrative exophthalmos after Iodine 131 treatment [ Time Frame: one year ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
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

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.

no more description

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Caregiver, Investigator)
Primary Purpose: Prevention
  • Hypothyroidism
  • Exophthalmos
Radiation: Iodine 131
iodine 131,185、370、555mBq,6 months
No Intervention: follow-up
Intervention: Radiation: Iodine 131
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
627
December 2016
July 2016   (final data collection date for primary outcome measure)

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
Both
8 Years to 90 Years
No
Contact: ningyi jiang, bachelor +8613602753179 ningyij@163.net
China
 
NCT01204359
2007022
Yes
ningyi jiang, SUN YAT-SEN UNIVERSITY
Sun Yat-sen University
Not Provided
Principal Investigator: SUN YAT-SEN UNIVERSITY ningyi jiang, professor Sun Yat-sen University
Sun Yat-sen University
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP