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

Graves' Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02114619
• Other study ID #: 920800
• Status: Recruiting
• Phase: N/A
• First received: April 12, 2014
• Last updated: April 14, 2014
• Start date: May 2013
• Est. completion date: December 2016

Study information

• Verified date: April 2014
• Source: Mashhad University of Medical Sciences
• Contact: Seyed Rasoul Zakavi, MD. IBNM
• Phone: +98-511 8012799
• Email: Zakavir[@]mums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Research Deputy of medical school, Mashhad University of Medical Sciences
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 450
• Est. completion date: December 2016
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Pregnancy or lactation

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Graves Disease
• Graves' Disease

Intervention

Drug:
• Low dose of I-131
We wil administer 100 micro currie of iodine per thyroid gram
• Intermediate dose
We will administer 150 micro currie of iodine per thyroid gram
• High dose
We will administer 200 micro currie of iodine per thyroid gram

Locations

Country	Name	City	State
Iran, Islamic Republic of	Nuclear Medicine Research Center, Ghaem Hospital	Mashhad	Khorasan-Razavi

Sponsors (1)

Lead Sponsor	Collaborator
Mashhad University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of thyroid volume	Change of thyroid volume 1,3,6 and 12 months after therapy using ultrasonography	1,3,6 and 12 months	No
Primary	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	Yes
Secondary	Rate of hypothyroidism status at 1, 3,6 and 12 month post RAI therapy	Hypothyroidism index	1,3,6,12 month	Yes