The Prospective Study of Standard Treatment of Graves Disease Iodine 131 and Prevention of Adverse Reactions
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hypothyroidism Exophthalmos |
Radiation: Iodine 131 |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Caregiver, Investigator) Primary Purpose: Prevention |
| Official Title: | "5010 Clinical Research Programme"of Sun Yat-sen University |
- The rate of Hypothyroidism after Iodine 131 treatment [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- The side effect to Infiltrative exophthalmos after Iodine 131 treatment [ Time Frame: one year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 627 |
| Study Start Date: | July 2007 |
| Estimated Study Completion Date: | December 2016 |
| Estimated Primary Completion Date: | July 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| No Intervention: follow-up |
Radiation: Iodine 131
iodine 131,185、370、555mBq,6 months
|
Detailed Description:
no more description
Eligibility| Ages Eligible for Study: | 8 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts 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
Contacts and Locations| Contact: ningyi jiang, bachelor | +8613602753179 | ningyij@163.net |
| China, Guangdong | |
| Sun Yat-sen Memorial Hospital | Recruiting |
| Guangzhou, Guangdong, China, 510120 | |
| Contact: Ningyi Jiang, bachelor +8613602753179 ningyij@163.net | |
| China | |
| Ningyi Jiang | Recruiting |
| Guangzhou, China | |
| Principal Investigator: | SUN YAT-SEN UNIVERSITY ningyi jiang, professor | Sun Yat-sen University |
More Information
No publications provided
| Responsible Party: | ningyi jiang, SUN YAT-SEN UNIVERSITY |
| ClinicalTrials.gov Identifier: | NCT01204359 History of Changes |
| Other Study ID Numbers: | 2007022 |
| Study First Received: | September 15, 2010 |
| Last Updated: | September 27, 2010 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Exophthalmos Hypothyroidism Orbital Diseases Eye Diseases Thyroid Diseases Endocrine System Diseases Iodine Cadexomer iodine |
Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Pharmacologic Actions Trace Elements Micronutrients Growth Substances Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on June 18, 2013