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

Sponsor

Mashhad University of Medical Sciences (Other)

Overall Status

Unknown status

CT.gov ID

NCT02114619

Collaborator

(none)

450

Enrollment

Location

Arms

Duration (Months)

10.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Graves' Disease	Drug: Low dose of I-131 Drug: Intermediate dose Drug: High dose	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

450 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

May 1, 2013

Anticipated Primary Completion Date :

Dec 1, 2014

Anticipated Study Completion Date :

Dec 1, 2016

Arms and Interventions

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

Arm

Intervention/Treatment

Active Comparator: 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

Drug: Low dose of I-131

We wil administer 100 micro currie of iodine per thyroid gram

Active Comparator: Intermediate dose

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

Drug: Intermediate dose

We will administer 150 micro currie of iodine per thyroid gram

Active Comparator: High dose

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

Drug: High dose

We will administer 200 micro currie of iodine per thyroid gram

Outcome Measures

Primary Outcome Measures

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

Rate of hypothyroidism status at 1, 3,6 and 12 month post RAI therapy [1,3,6,12 month]
Hypothyroidism index

Other Outcome Measures

Change of thyroid volume [1,3,6 and 12 months]
Change of thyroid volume 1,3,6 and 12 months after therapy using ultrasonography

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age 18-65 hyperthyroid patients (Graves'disease)

Exclusion Criteria:

Pregnancy or lactation

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Nuclear Medicine Research Center, Ghaem Hospital	Mashhad	Khorasan-Razavi	Iran, Islamic Republic of	9919991766

Sponsors and Collaborators

Mashhad University of Medical Sciences

Investigators

Study Director: Narjess Ayati, MD, FEBNM, Nuclear Medicine Research Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

S.R.ZAKAVI, Head of Nuclear Medicine Research Center, Mashhad University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT02114619

Other Study ID Numbers:

920800

First Posted:

Apr 15, 2014

Last Update Posted:

Apr 15, 2014

Last Verified:

Apr 1, 2014

Keywords provided by S.R.ZAKAVI, Head of Nuclear Medicine Research Center, Mashhad University of Medical Sciences

Additional relevant MeSH terms:

Graves Disease

Study Results

No Results Posted as of Apr 15, 2014