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

Primary Purpose

Hypothyroidism, Exophthalmos

Status
Unknown status
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Iodine 131
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypothyroidism

Eligibility Criteria

8 Years - 90 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sun Yat-sen Memorial HospitalRecruiting
  • Ningyi JiangRecruiting

Arms of the Study

Arm 1

Arm Type

No Intervention

Arm Label

follow-up

Arm Description

Outcomes

Primary Outcome Measures

The rate of Hypothyroidism after Iodine 131 treatment

Secondary Outcome Measures

The side effect to Infiltrative exophthalmos after Iodine 131 treatment

Full Information

First Posted
September 15, 2010
Last Updated
May 22, 2015
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT01204359
Brief Title
The Prospective Study of Standard Treatment of Graves Disease Iodine 131 and Prevention of Adverse Reactions
Official Title
"5010 Clinical Research Programme"of Sun Yat-sen University
Study Type
Interventional

2. Study Status

Record Verification Date
May 2015
Overall Recruitment Status
Unknown status
Study Start Date
July 2007 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
December 2016 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Sun Yat-sen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypothyroidism, Exophthalmos

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
627 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
follow-up
Arm Type
No Intervention
Intervention Type
Radiation
Intervention Name(s)
Iodine 131
Intervention Description
iodine 131,185、370、555mBq,6 months
Primary Outcome Measure Information:
Title
The rate of Hypothyroidism after Iodine 131 treatment
Time Frame
one year
Secondary Outcome Measure Information:
Title
The side effect to Infiltrative exophthalmos after Iodine 131 treatment
Time Frame
one year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ningyi jiang, bachelor
Phone
+8613602753179
Email
ningyij@163.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SUN YAT-SEN UNIVERSITY ningyi jiang, professor
Organizational Affiliation
Sun Yat-sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen Memorial Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510120
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ningyi Jiang, bachelor
Phone
+8613602753179
Email
ningyij@163.net
Facility Name
Ningyi Jiang
City
Guangzhou
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

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

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