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

NCT ID: NCT02114619

Last Updated: 2014-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

450 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2016-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Graves' Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Low dose of I-131

Intervention Type DRUG

We wil administer 100 micro currie of iodine per thyroid gram

Intermediate dose

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

Group Type ACTIVE_COMPARATOR

Intermediate dose

Intervention Type DRUG

We will administer 150 micro currie of iodine per thyroid gram

High dose

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

Group Type ACTIVE_COMPARATOR

High dose

Intervention Type DRUG

We will administer 200 micro currie of iodine per thyroid gram

Interventions

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Low dose of I-131

We wil administer 100 micro currie of iodine per thyroid gram

Intervention Type DRUG

Intermediate dose

We will administer 150 micro currie of iodine per thyroid gram

Intervention Type DRUG

High dose

We will administer 200 micro currie of iodine per thyroid gram

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnancy or lactation
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mashhad University of Medical Sciences

OTHER

Sponsor Role lead

Responsible Party

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S.R.ZAKAVI

Head of Nuclear Medicine Research Center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Narjess Ayati, MD, FEBNM

Role: STUDY_DIRECTOR

Nuclear Medicine Research Center

Locations

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Nuclear Medicine Research Center, Ghaem Hospital

Mashhad, Khorasan-Razavi, Iran

Site Status RECRUITING

Countries

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Iran

Central Contacts

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Seyed Rasoul Zakavi, MD. IBNM

Role: CONTACT

+98-511 8012799

Narjess Ayati, MD. FEBNM

Role: CONTACT

+98-511 8012782

Facility Contacts

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Zohre Mousavi, MD. IBE

Role: primary

+98-5118599359

Other Identifiers

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920800

Identifier Type: -

Identifier Source: org_study_id

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