Graves' DiseaseNCT02114619
Comparative Study of Different I-131 Doses in Graves' Disease
A study testing Low dose of I-131, Intermediate dose and High dose in people with Graves' Disease, run by Mashhad University of Medical Sciences at 1 site in Iran.
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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graves' Disease
- What is being tested?
- Low dose of I-131, Intermediate dose and High dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- 1 siteIran
- Study dates
- May 2013to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 hyperthyroid patients (Graves'disease)
Who cannot join
- Pregnancy or lactation
Trial locations and contacts
1 site in 1 country.
Iran1 site, 1 recruiting
- Recruiting
Nuclear Medicine Research Center, Ghaem Hospital
Mashhad, Razavi Khorasan Province, 9919991766
Zohre Mousavi, MD. IBE, +98-5118599359, Mosaviz@mums.ac.ir
Ramin Sadeghi, MD. IBNM
About this study
Official title: 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.
- Conditions
- Graves' Disease
- Being tested
- Low dose of I-131, Intermediate dose, High dose
- Keywords
- radioiodine therapy, Graves' disease, Hyperthyroidism, calculated dose
- Medical subject headings
- Graves Disease, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low dose of I-131Drug
We wil administer 100 micro currie of iodine per thyroid gram
Intermediate doseDrug
We will administer 150 micro currie of iodine per thyroid gram
High doseDrug
We will administer 200 micro currie of iodine per thyroid gram
| Study group | Role | What they receive |
|---|---|---|
| Low dose of I-131 | Active comparator | Patients with Graves' disease who will be treated with I-131, using 100 microcurie per gram (uCi/gr) of thyroid weight Receives: Drug: Low dose of I-131 |
| Intermediate dose | Active comparator | Patients with Graves' disease who will be treated with 150 microcurie (uCi) of I-131 per gram of thyroid weight. Receives: Drug: Intermediate dose |
| High dose | Active comparator | Patients with Graves' disease who will be treated with I-131 using 200 uCi/gr of thyroid weight. Receives: Drug: High dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
change of thyroid related hormones blood level from baseline at 1,3,6 and 12 month
thyroid-stimulating hormone (TSH), T4, T3
Measured: 1,3,6,12 month
Secondary outcomes (1)
Rate of hypothyroidism status at 1, 3,6 and 12 month post RAI therapy
Hypothyroidism index
Measured: 1,3,6,12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startMay 2013
- Primary completionDec 2014 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves' DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, S.R.ZAKAVI, Mashhad University of Medical Sciences
- Investigators
- Narjess Ayati, MD, FEBNM, Study director, Nuclear Medicine Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114619
- Sponsor's protocol ID
- 920800
- Status last verified
- Apr 2014
- First submitted
- 12 Apr 2014
- Last updated
- 15 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Different Calculated Doses of I-131 in Treatment of Patients With Grave's Disease
- ClinicalTrials.gov ID
- NCT02114619
- Acronym / sponsor ID
- 920800
- Conditions
- Graves' Disease
- Keywords
- radioiodine therapy, Graves' disease, Hyperthyroidism, calculated dose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Low dose of I-131 | Active comparator | Drug: Low dose of I-131Patients with Graves' disease who will be treated with I-131, using 100 microcurie per gram (uCi/gr) of thyroid weight |
| Intermediate dose | Active comparator | Drug: Intermediate dosePatients with Graves' disease who will be treated with 150 microcurie (uCi) of I-131 per gram of thyroid weight. |
| High dose | Active comparator | Drug: High dosePatients with Graves' disease who will be treated with I-131 using 200 uCi/gr of thyroid weight. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age 18-65 hyperthyroid patients (Graves'disease)
Key exclusion criteria (1 listed)
- Pregnancy or lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low dose of I-131We wil administer 100 micro currie of iodine per thyroid gram | Drug | Low dose of I-131 |
| Intermediate doseWe will administer 150 micro currie of iodine per thyroid gram | Drug | Intermediate dose |
| High doseWe will administer 200 micro currie of iodine per thyroid gram | Drug | High dose |
Primary outcome
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 secondary outcome
Rate of hypothyroidism status at 1, 3,6 and 12 month post RAI therapy
Time frame: 1,3,6,12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Narjess Ayati, MD, FEBNM study director
Nuclear Medicine Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low dose of I-131, Intermediate dose and High dose in people with Graves' Disease, run by Mashhad University of Medical Sciences at 1 site in Iran.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iran. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Seyed Rasoul Zakavi, MD. IBNM (+98-511 8012799, Zakavir@mums.ac.ir), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change of thyroid related hormones blood level from baseline at 1,3,6 and 12 month (time frame: 1,3,6,12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2014.