Comparative Study of Different I-131 Doses in Graves' Disease
The Effect of Different Calculated Doses of I-131 in Treatment of Patients With Grave's Disease
1 other identifier
interventional
450
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started May 2013
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2013
CompletedFirst Submitted
Initial submission to the registry
April 12, 2014
CompletedFirst Posted
Study publicly available on registry
April 15, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedApril 15, 2014
April 1, 2014
1.6 years
April 12, 2014
April 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Secondary Outcomes (1)
Rate of hypothyroidism status at 1, 3,6 and 12 month post RAI therapy
1,3,6,12 month
Other Outcomes (1)
Change of thyroid volume
1,3,6 and 12 months
Study Arms (3)
Low dose of I-131
ACTIVE COMPARATORPatients with Graves' disease who will be treated with I-131, using 100 microcurie per gram (uCi/gr) of thyroid weight
Intermediate dose
ACTIVE COMPARATORPatients with Graves' disease who will be treated with 150 microcurie (uCi) of I-131 per gram of thyroid weight.
High dose
ACTIVE COMPARATORPatients with Graves' disease who will be treated with I-131 using 200 uCi/gr of thyroid weight.
Interventions
We will administer 150 micro currie of iodine per thyroid gram
Eligibility Criteria
You may qualify if:
- Age 18-65 hyperthyroid patients (Graves'disease)
You may not qualify if:
- Pregnancy or lactation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Nuclear Medicine Research Center, Ghaem Hospital
Mashhad, Khorasan-Razavi, 9919991766, Iran
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Narjess Ayati, MD, FEBNM
Nuclear Medicine Research Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Nuclear Medicine Research Center
Study Record Dates
First Submitted
April 12, 2014
First Posted
April 15, 2014
Study Start
May 1, 2013
Primary Completion
December 1, 2014
Study Completion
December 1, 2016
Last Updated
April 15, 2014
Record last verified: 2014-04