Protocol summary

Summary
Radioiodine therapy is an effective treatment in hyperthyroidism. However there is no consensus on the optimal dose regimen of I-131 administration. We aim to compare the efficacy of different fixed versus different calculated doses of I-131 in treatment of patients with Graves' disease.This is a clinical randomized trial on 300 Graves' patients whom are referred for radioiodine therapy to nuclear medicine department of Ghaem hospital. After signing the written consent, the patients will be randomly treated with different fixed and calculated doses of 131 iodine and the treatment response as well as complications of treatment will be compared between different groups at 1, 3, 6 and 12 months post iodine therapy.

General information

Acronym
MASRIG
IRCT registration information
IRCT registration number: IRCT2016020217006N1
Registration date: 2017-09-10, 1396/06/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-09-10, 1396/06/19
Registrant information
Name
Narjess Khatoun Ayati
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 1801 2782
Email address
ayatin@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-03-01, 1393/12/10
Expected recruitment end date
2019-03-02, 1397/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between different fixed and calculated doses of I-131 in treatment of patients with Graves' disease
Public title
Radioiodine therapy in Graves' disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age more than 18; Confirmed cases of Graves' disease; No previous history of radioiodine therapy;No previous history of thyroid surgery Exclusion criteria: pregnancy; lactation; severe ophtalmopathy; no desire to join to study
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 300
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
F2. Ghoreishi Building. Daneshgah Street. Mashhad
City
Mashhad
Postal code
Approval date
2014-01-29, 1392/11/09
Ethics committee reference number
920800

Health conditions studied

1

Description of health condition studied
Graves
ICD-10 code
E05.0
ICD-10 code description
Thyrotoxicosis with diffuse goiter

Primary outcomes

1

Description
TSH, T3, T4
Timepoint
1,3,6,12 months post radioiodine therapy
Method of measurement
Blood test

2

Description
Thyroid volume
Timepoint
1,3,6,12 months post radioiodine therapy
Method of measurement
Ultrasonography

3

Description
Thyroid weight
Timepoint
1,3,6,12 months post radioiodine therapy
Method of measurement
Physical examination

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Fixed Low Dose (7 mCi)I-131/Single dose
Category
Treatment - Drugs

2

Description
Intervention group: Fixed High Dose (15 mCi) I-131/Single dose
Category
Treatment - Drugs

3

Description
Intervention group: Calculated Dose (100 micro Currie I-131/gr Thyroid tissue) / Single dose
Category
Treatment - Drugs

4

Description
Intervention group: Calculated Dose (150 micro Currie I-131/gr Thyroid tissue) / Single dose
Category
Treatment - Drugs

5

Description
Intervention group: Calculated Dose (200 micro Currie I-131/gr Thyroid tissue) / Single dose
Category
Treatment - Drugs

6

Description
Intervention group: Calculated Dose (300 micro Currie I-131/gr Thyroid tissue) / Single dose
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Nuclear Medicine Research Center
Full name of responsible person
Dr. Narjes Ayati
Street address
Ahmadabad Street, Mashhad
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Dr. Mohsen. Tafaghodi
Street address
F2. Ghoreishi Building. Daneshgah Street. Mashhad
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences, Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Ghaem Nuclear Medicine Reserch Center
Full name of responsible person
Dr. Narjess Ayati
Position
Assiastant Professor of Nuclear Mrdicine
Other areas of specialty/work
Street address
Ahmadabad Street, Mashhad
City
Mashhad
Postal code
9919991763
Phone
+98 51 3840 0494
Fax
+98 51 3840 0494
Email
AyatiN@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghaem Nuclear Medicine Research Center
Full name of responsible person
Dr. Seyed Rasoul Zakavi
Position
Nuclear Medicine Specialist/Professor
Other areas of specialty/work
Street address
Ahmadabad Street, Mashhad
City
Mashhad
Postal code
9919991763
Phone
+98 51 3840 0494
Fax
+98 51 3840 0494
Email
Zakavir@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Ghaem Nuclear Medicine Research Center
Full name of responsible person
Dr. Narjes Ayati
Position
Nuclear Medicine Specialist/Assistant Professor
Other areas of specialty/work
Street address
Ahmadabad Street, Mashhad
City
Mashhad
Postal code
9919991763
Phone
+98 51 3840 0494
Fax
+98 51 3840 0494
Email
AyatiN@mums.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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