Optimum dose finding in radioiodine treatment of hyperthyroidism in Graves' disease
| ISRCTN | ISRCTN62749892 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN62749892 |
| Secondary identifying numbers | 1.0 |
- Submission date
- 23/11/2009
- Registration date
- 20/01/2010
- Last edited
- 11/10/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Dan Yun Chen
Scientific
Scientific
Sun Yat-sen University
The First Affiliated Hospital
Dongshan Division
Hyperthyroidism Treatment Center
Zhongshan Road Ⅱ, 1st
Guangzhou
510080
China
| chendanyun@sohu.com |
Study information
| 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 |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant 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 |
| Scientific title | 12-year prospective, randomised, open-label blinded endpoint study (PROBE) to estimate the optimum dose for radioiodine treatment of Graves' disease |
| Study objectives | 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(s) | Dongshan Ethics Committee approved in April 1997 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 20/04/1997 |
| Completion date | 31/12/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | Both |
| Target number of participants | 600 patients randomised to 5 groups of 120 each |
| Key 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 |
| Key exclusion criteria | 1. Severe liver or kidney damage 2. Agranulocytosis 3. Pregnancy or lactation 4. Less than 8 years of age |
| Date of first enrolment | 20/04/1997 |
| Date of final enrolment | 31/12/2009 |
Locations
Countries of recruitment
- China
Study participating centre
Sun Yat-sen University
Guangzhou
510080
China
510080
China
Sponsor information
Sun Yat-Sen University (China)
University/education
University/education
The First Affiliated Hospital
Zhongshan Road Ⅱ, 1st
Guangzhou
510080
China
| chendanyun@sohu.com | |
| Website | http://www.gzsums.net/yiyxx/e-yiygaik.asp |
"ROR" |
https://ror.org/0064kty71 |
Funders
Funder type
University/education
Sun Yat-Sen University (China)
Private sector organisation / Universities (academic only)
Private sector organisation / Universities (academic only)
- Alternative name(s)
- SYSU
- Location
- China
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2011 | Yes | No |
