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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Mashhad University of Medical Sciences
Sponsor:
Information provided by (Responsible Party):
S.R.ZAKAVI, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT02114619
First received: April 12, 2014
Last updated: April 14, 2014
Last verified: April 2014
  Purpose

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 Intervention
Graves' Disease
Drug: Low dose of I-131
Drug: Intermediate dose
Drug: High dose

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Different Calculated Doses of I-131 in Treatment of Patients With Grave's Disease

Resource links provided by NLM:


Further study details as provided by Mashhad University of Medical Sciences:

Primary Outcome Measures:
  • change of thyroid related hormones blood level from baseline at 1,3,6 and 12 month [ Time Frame: 1,3,6,12 month ] [ Designated as safety issue: Yes ]
    thyroid-stimulating hormone (TSH), T4, T3


Secondary Outcome Measures:
  • Rate of hypothyroidism status at 1, 3,6 and 12 month post RAI therapy [ Time Frame: 1,3,6,12 month ] [ Designated as safety issue: Yes ]
    Hypothyroidism index


Other Outcome Measures:
  • Change of thyroid volume [ Time Frame: 1,3,6 and 12 months ] [ Designated as safety issue: No ]
    Change of thyroid volume 1,3,6 and 12 months after therapy using ultrasonography


Estimated Enrollment: 450
Study Start Date: May 2013
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Pregnancy or lactation
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02114619

Contacts
Contact: Seyed Rasoul Zakavi, MD. IBNM +98-511 8012799 Zakavir@mums.ac.ir
Contact: Narjess Ayati, MD. FEBNM +98-511 8012782 Ayatin@mums.ac.ir

Locations
Iran, Islamic Republic of
Nuclear Medicine Research Center, Ghaem Hospital Recruiting
Mashhad, Khorasan-Razavi, Iran, Islamic Republic of, 9919991766
Contact: Zohre Mousavi, MD. IBE    +98-5118599359    Mosaviz@mums.ac.ir   
Sub-Investigator: Ramin Sadeghi, MD. IBNM         
Principal Investigator: Seyed Rasoul Zakavi, MD. IBNM         
Sponsors and Collaborators
Mashhad University of Medical Sciences
Investigators
Study Director: Narjess Ayati, MD, FEBNM Nuclear Medicine Research Center
  More Information

No publications provided

Responsible Party: S.R.ZAKAVI, Head of Nuclear Medicine Research Center, Mashhad University of Medical Sciences
ClinicalTrials.gov Identifier: NCT02114619     History of Changes
Other Study ID Numbers: 920800
Study First Received: April 12, 2014
Last Updated: April 14, 2014
Health Authority: Iran: Research Deputy of medical school, Mashhad University of Medical Sciences

Keywords provided by Mashhad University of Medical Sciences:
radioiodine therapy
Graves' disease
Hyperthyroidism
calculated dose

Additional relevant MeSH terms:
Graves Disease
Exophthalmos
Orbital Diseases
Eye Diseases
Goiter
Thyroid Diseases
Endocrine System Diseases
Hyperthyroidism
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on August 01, 2014