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
  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

Resource links provided by NLM:


Further study details as provided by Sun Yat-sen University:

Primary Outcome Measures:
  • The rate of Hypothyroidism after Iodine 131 treatment [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • 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
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01204359

Contacts
Contact: ningyi jiang, bachelor +8613602753179 ningyij@163.net

Locations
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
Sponsors and Collaborators
Sun Yat-sen University
Investigators
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 August 28, 2014