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

Mashhad University of Medical Sciences

Status: Unknown

Conditions: Graves' Disease

Treatments: Drug: Intermediate dose; Drug: Low dose of I-131; Drug: High dose

Study type: Interventional

Funder types: Other

Identifiers

NCT02114619

920800

Details and patient eligibility

About

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.

Enrollment: 450 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

• Pregnancy or lactation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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450 participants in 3 patient groups

Low dose of I-131

Active Comparator group

Description:

Patients with Graves' disease who will be treated with I-131, using 100 microcurie per gram (uCi/gr) of thyroid weight

Treatment:

Drug: Low dose of I-131

Intermediate dose

Active Comparator group

Description:

Patients with Graves' disease who will be treated with 150 microcurie (uCi) of I-131 per gram of thyroid weight.

Treatment:

Drug: Intermediate dose

High dose

Active Comparator group

Description:

Patients with Graves' disease who will be treated with I-131 using 200 uCi/gr of thyroid weight.

Treatment:

Drug: High dose