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

NCT01204359 | Unknown Phase 3 DMC

• 1 other identifier: 2007022
• Study Type: interventional
• Target: 627
• Locations: 1 country
• Sites: 2

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.

Conditions

Hypothyroidism; Exophthalmos

Outcome Measures

Primary Outcomes (1)

• The rate of Hypothyroidism after Iodine 131 treatment

  one year

Secondary Outcomes (1)

• The side effect to Infiltrative exophthalmos after Iodine 131 treatment

  one year

Study Arms (1)

follow-up

NO INTERVENTION

Radiation: Iodine 131

Interventions

Iodine 131 RADIATION

iodine 131，185、370、555mBq，6 months

follow-up

Eligibility Criteria

• Age: 8 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• I 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

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (2)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510120, China

RECRUITING

Ningyi Jiang

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Hypothyroidism; Exophthalmos

Interventions

Iodine-131

Condition Hierarchy (Ancestors)

Thyroid Diseases; Endocrine System Diseases; Orbital Diseases; Eye Diseases

Study Officials

• SUN YAT-SEN UNIVERSITY ningyi jiang, professor

  Sun Yat-sen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ningyi jiang, bachelor

CONTACT

+8613602753179; ningyij@163.net

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 15, 2010
• First Posted: September 17, 2010
• Study Start: July 1, 2007
• Primary Completion: July 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 25, 2015

Record last verified: 2015-05

Locations

CN (2)