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

Not Applicable

• Conditions: Graves' Disease
• Interventions: Drug: Low dose of I-131; Drug: Intermediate dose; Drug: High dose

• Registration Number: NCT02114619
• Lead Sponsor: Mashhad University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-05
• Status Verified: 2014-04
• Study First Submitted: 2014-04-12
• Study First Submitted QC: 2014-04-14
• Last Update Submitted: 2014-04-14
• Study First Posted: 2014-04-15
• Last Update Posted: 2014-04-15
• Primary Completion: 2014-12
• Study Completion: 2016-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 450

Inclusion Criteria

• Age 18-65 hyperthyroid patients (Graves'disease)

Exclusion Criteria

• Pregnancy or lactation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low dose of I-131	Low dose of I-131	Patients with Graves' disease who will be treated with I-131, using 100 microcurie per gram (uCi/gr) of thyroid weight
Intermediate dose	Intermediate dose	Patients with Graves' disease who will be treated with 150 microcurie (uCi) of I-131 per gram of thyroid weight.
High dose	High dose	Patients with Graves' disease who will be treated with I-131 using 200 uCi/gr of thyroid weight.

Primary Outcome Measures

Name	Time	Method
change of thyroid related hormones blood level from baseline at 1,3,6 and 12 month	1,3,6,12 month	thyroid-stimulating hormone (TSH), T4, T3

Secondary Outcome Measures

Name	Time	Method
Rate of hypothyroidism status at 1, 3,6 and 12 month post RAI therapy	1,3,6,12 month	Hypothyroidism index

Trial Locations

Locations (1)

Nuclear Medicine Research Center, Ghaem Hospital; 🇮🇷 Mashhad, Khorasan-Razavi, Iran, Islamic Republic of