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

April 14, 2014 updated by: S.R.ZAKAVI, Mashhad University of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

450

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
    • Khorasan-Razavi
      • Mashhad, Khorasan-Razavi, Iran, Islamic Republic of, 9919991766
        • Recruiting
        • Nuclear Medicine Research Center, Ghaem Hospital
        • Contact:
        • Sub-Investigator:
          • Ramin Sadeghi, MD. IBNM
        • Principal Investigator:
          • Seyed Rasoul Zakavi, MD. IBNM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy or lactation

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

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
Time Frame: 1,3,6,12 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
Time Frame: 1,3,6,12 month
Hypothyroidism index
1,3,6,12 month

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of thyroid volume
Time Frame: 1,3,6 and 12 months
Change of thyroid volume 1,3,6 and 12 months after therapy using ultrasonography
1,3,6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mashhad University of Medical Sciences

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Anticipated)

December 1, 2014

Study Completion (Anticipated)

December 1, 2016

Study Registration Dates

First Submitted

April 12, 2014

First Submitted That Met QC Criteria

April 14, 2014

First Posted (Estimate)

April 15, 2014

Study Record Updates

Last Update Posted (Estimate)

April 15, 2014

Last Update Submitted That Met QC Criteria

April 14, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 920800

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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