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ISRCTN
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ISRCTN62749892
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ClinicalTrials.gov identifier
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Public title
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Optimum dose finding in radioiodine treatment of hyperthyroidism in Graves' disease
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Scientific title
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12-year prospective, randomised, open-label blinded endpoint study (PROBE) to estimate the optimum dose for radioiodine treatment of Graves' disease
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Acronym
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N/A
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Serial number at source
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1.0
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Study hypothesis
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Dose optimisation in Graves' disease has been targeted such as to avoid a large number of recurrences or uncured patients. There was no particular focus on a low hypothyroidism rate. We hypothesise that there is an optimum individual dose resulting in a lowest uncured hyperthyroidism or recurrence rate and a low hypothyroidism rate at the same dose concept. An optimised dose concept would be desirable for two reasons:
1. To limit use of 131I for radiation safety issues
2. To limit hypothyroidism rate and consecutive need of replacement therapy. It seems to be an important factor in regions where patients have limited resources or, where access to medical supplies is limited.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Dongshan Ethics Committee approved in April 1997
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Study design
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Prospective randomised open-label blinded end point study with intention-to-treat principle
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Countries of recruitment
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China
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Disease/condition/study domain
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Graves' disease
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Participants - inclusion criteria
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1. Newly diagnosed hyperthyroid patients diagnosed Graves' disease
2. Patients with Graves' disease and anti thyroid drugs after 2 weeks withdrawal
3. Elevated levels of a recent set of general serum and thyroid function tests, confirming hyperthyroidism
4. 24-hour 131I-uptake greater than or equal to 40%
5. If 131I-uptake less than 40%, restriction of food or drug rich in iodine, retest until uptake was greater than or equal to 40%
6. Aged 8 years to no age limit, males and females
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Participants - exclusion criteria
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1. Severe liver or kidney damage
2. Agranulocytosis
3. Pregnancy or lactation
4. Less than 8 years of age
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Anticipated start date
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20/04/1997
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Anticipated end date
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31/12/2009
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please contact either schneider_P@nuklearmedizin.uni-wuerzburg.de (for a translated English version) or chendanyun@sohu.com (for a Chinese version) to request a patient information sheet
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Target number of participants
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600 patients randomised to 5 groups of 120 each
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Interventions
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Intervention group: Participants received one application of 131I (oral), followed by a second application after 3 months, if the first was unsuccessful. The dose/activity of 131I (in MBq) was determined using a clinical score system, the gland mass, and the 24 hours uptake of a test activity. Follow up was initially two-weekly, then monthly, and, after the patient became stable in 6-monthly intervals.
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Primary outcome measure(s)
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Assessed annually, that is every 12 months after first therapeutic intervention for each patient, ending year 12:
1. Euthyroidism
2. Hyperthyroidism
3. Recurrence
4. Hypothyroidism
5. Subclinical hypothyroidism
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Secondary outcome measure(s)
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The sum dose of 131-radioiodine which was necessary to achieve therapeutic primary outcomes at the end of the study. It was assessed 3 months after inclusion and after a patient had administered or not a second treatment dose. The outcomes measure resulted from 5 groups of dose-ranges of radioiodine, beginning with a low dose-range and ending with a high dose-range. The individual dose to be adminstered was determined according to these 5 range groups modulated by a clinical 7 step score.
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Sources of funding
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Sun Yat-Sen University (China)
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Trial website
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Publications
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2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21563916
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Contact name
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Prof
Dan Yun
Chen
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Address
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Sun Yat-sen University
The First Affiliated Hospital
Dongshan Division
Hyperthyroidism Treatment Center
Zhongshan Road Ⅱ, 1st
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City/town
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Guangzhou
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Zip/Postcode
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510080
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Country
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China
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Email
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chendanyun@sohu.com
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Sponsor
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Sun Yat-Sen University (China)
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Address
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The First Affiliated Hospital
Zhongshan Road Ⅱ, 1st
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City/town
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Guangzhou
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Zip/Postcode
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510080
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Country
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China
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Email
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chendanyun@sohu.com
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Sponsor website:
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http://www.gzsums.net/yiyxx/e-yiygaik.asp
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Date applied
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23/11/2009
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Last edited
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11/10/2011
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Date ISRCTN assigned
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20/01/2010
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