Contact information
Type
Scientific
Primary contact
Prof Dan Yun Chen
ORCID ID
Contact details
Sun Yat-sen University
The First Affiliated Hospital
Dongshan Division
Hyperthyroidism Treatment Center
Zhongshan Road Ⅱ
1st
Guangzhou
510080
China
chendanyun@sohu.com
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1.0
Study information
Scientific title
12-year prospective, randomised, open-label blinded endpoint study (PROBE) to estimate the optimum dose for radioiodine treatment of Graves' disease
Acronym
Study hypothesis
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.
Ethics approval
Dongshan Ethics Committee approved in April 1997
Study design
Prospective randomised open-label blinded end point study with intention-to-treat principle
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
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
Condition
Graves' disease
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Radioiodine
Primary outcome measure
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
Secondary outcome measures
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.
Overall trial start date
20/04/1997
Overall trial end date
31/12/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
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
Participant type
Patient
Age group
Other
Gender
Both
Target number of participants
600 patients randomised to 5 groups of 120 each
Participant exclusion criteria
1. Severe liver or kidney damage
2. Agranulocytosis
3. Pregnancy or lactation
4. Less than 8 years of age
Recruitment start date
20/04/1997
Recruitment end date
31/12/2009
Locations
Countries of recruitment
China
Trial participating centre
Sun Yat-sen University
Guangzhou
510080
China
Sponsor information
Organisation
Sun Yat-Sen University (China)
Sponsor details
The First Affiliated Hospital
Zhongshan Road Ⅱ
1st
Guangzhou
510080
China
chendanyun@sohu.com
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Sun Yat-Sen University (China)
Alternative name(s)
SYSU
Funding Body Type
private sector organisation
Funding Body Subtype
academic
Location
China
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21563916
Publication citations
-
Results
Chen DY, Schneider PF, Zhang XS, He ZM, Jing J, Chen TH, Striving for euthyroidism in radioiodine therapy of Graves' disease: a 12-year prospective, randomized, open-label blinded end point study., Thyroid, 2011, 21, 6, 647-654, doi: 10.1089/thy.2010.0348.