Comparative Study of Different I-131 Doses in Graves' Disease

Study Overview
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Brief Summary
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Radioactive iodine (RAI) administration is an effective and completely established treatment modality in hyperthyroidism including Graves' disease. Despite the long experience with radioiodine for hyperthyroidism, controversy remains regarding the optimal dose of iodine that is required to achieve long-term euthyroidism. The fixed activity administration method does not optimize the therapy, giving often too high or too low radiation to the gland, but the optimal dose per gram of thyroid mass in calculated activity administration method is also under much debates. This prospective study has been designed in order to compare the effect of different calculated doses of radioiodine on Graves' disease treatment outcome.

Official Title
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The Effect of Different Calculated Doses of I-131 in Treatment of Patients With Grave's Disease

Conditions
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Graves' Disease

Intervention / Treatment
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* Drug: Low dose of I-131
* Drug: Intermediate dose
* Drug: High dose


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18-65 hyperthyroid patients (Graves'disease) Exclusion Criteria: Pregnancy or lactation

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low dose of I-131<br>Patients with Graves' disease who will be treated with I-131, using 100 microcurie per gram (uCi/gr) of thyroid weight | Drug: Low dose of I-131<br>* We wil administer 100 micro currie of iodine per thyroid gram<br>|
| Active Comparator: Intermediate dose<br>Patients with Graves' disease who will be treated with 150 microcurie (uCi) of I-131 per gram of thyroid weight. | Drug: Intermediate dose<br>* We will administer 150 micro currie of iodine per thyroid gram<br>|
| Active Comparator: High dose<br>Patients with Graves' disease who will be treated with I-131 using 200 uCi/gr of thyroid weight. | Drug: High dose<br>* We will administer 200 micro currie of iodine per thyroid gram<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of thyroid related hormones blood level from baseline at 1,3,6 and 12 month | thyroid-stimulating hormone (TSH), T4, T3 | 1,3,6,12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of hypothyroidism status at 1, 3,6 and 12 month post RAI therapy | Hypothyroidism index | 1,3,6,12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radioiodine therapy, Graves' disease, Hyperthyroidism, calculated dose