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Treatment efficacy of high versus low dose post thyroidectomy iodine ablation in intermediate risk patients with differentiated thyroid cancer , refering to thyroid clinic of nuclear medicine department of GHAEM hospital in the years 1392 to 1395.

Protocol summary

Summary
For radioiodine ablation in differentiated thyroid cancer patients, low dose of Iodine 131(30 milli-curies) is recommended for low risk patients and for high risk ones, high dose iodine 131(100 milli-curies or more) is recommended; however, there is no prompt recommendation for optimal dose of radioiodine ablation in intermediate risk patients. This study is aimed to compare the treatment efficacy of low versus high dose radioiodine therapy in intermediate risk thyroid cancer patients. This study will be carried out on 110 adult patients who place in intermediate risk category of differentiated thyroid carcinoma . They will be devided in two groups each containing 55 patients and will receive 30 or 150 milli-curies of I131 orally in one session, being randomized. After radioiodine therapy, They will be followed for1 year. The treatment response will be evaluated based on the laboratory data, ultrasonography and the diagnostic whole body iodine scan (if performed), after 1 year according to the new response assessment criteria based on the last published version of American Thyroid Association guidelines. The therapeutic response will be either excellent response, acceptable response or incomplete response. So, the therapeutic response of high(150 milli-curies) and low dose(30 milli-curies) radioiodine ablation in intermediate risk differentiated thyroid cancer patients will be evaluated and compared. Also, the possible relationshisp between age, sex, the first serum thyroglobulin and anti thyroglobulin levels with the therapeutic response will be illustrated, too.

General information

Acronym
LOH(low or high)
IRCT registration information
IRCT registration number: IRCT2016011626038N1
Registration date: 2016-05-08, 1395/02/19
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-08, 1395/02/19
Registrant information
Name
ََAthena Aghaee
Name of organization / entity
Mashhad University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 51 3840 6911
Email address
aghaeea911@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nuclear Medicine Research Center; Mashhad University of Medical Sciences
Expected recruitment start date
2014-12-31, 1393/10/10
Expected recruitment end date
2016-10-31, 1395/08/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Treatment efficacy of high versus low dose post thyroidectomy iodine ablation in intermediate risk patients with differentiated thyroid cancer , refering to thyroid clinic of nuclear medicine department of GHAEM hospital in the years 1392 to 1395.
Public title
comparing treatment efficacy of high versus low dose iodine ablation in intermediate risk thyroid cancer patients referring to thyroid clinic of nuclear medicine department of GHAEM hospital in the years 1392 to 1395
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion:age more than 18 years/ diagnosis of DTC by a reliable pathology/history of total thyroidectomy / recieved no other treatments such as radiotherapy and/or iodine ablation after surgery/ no evidence of distant metastasis at initial evaluation/ categorizing in either of these groups: age more than 45 yeras: T1N1b,T2N0,T2N1a,T3N0; age less than 45 years: T21a,T2N1b,T3N0,T3N1a Exclusion: incomplete thyroid surgery; first serum Throglobulin level more than 60 ng/dl; distant metastasis/ T4
Age
From 18 years old to 100 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 150
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mashhad University of Medical Sciences
Street address
Mashhad University of Medical Sciences, Park square, Mashhad
City
mashhad
Postal code
Approval date
2013-10-05, 1392/07/13
Ethics committee reference number
IR.MUMS.REC.1392.150

Health conditions studied

1

Description of health condition studied
Malignant neoplasm of thyroid gland
ICD-10 code
(C73)
ICD-10 code description
Malignant neoplasm of thyroid gland

Primary outcomes

1

Description
response to treatment categorize as 3 groups: excellent response, acceptable response and incomplete response
Timepoint
1 year after treament
Method of measurement
according to patients lab test in the off drug status, such as thyroglobulin, anti thyroglobulin , neck ultrasonography and diagostic whole body iodine scan,if needed

Secondary outcomes

1

Description
serum thyroglobulin
Timepoint
1 year after treatment
Method of measurement
lab data

Intervention groups

1

Description
administration of 150 mci of I131
Category
Treatment - Drugs

2

Description
administration of 30mci of I131.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Ghaem Hospital-Nuclear Medicine Department
Full name of responsible person
Dr.Athena Aghaee
Street address
Ghaem Hospital; Ahmad Abad Avenue
City
Mashhad

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Nuclear Medicine Research Center
Full name of responsible person
Dr.Seyed Rasool Zakavi
Street address
Ghaem Hospital
City
Mashhad
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Nuclear Medicine Research Center
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
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Athena Aghaee
Position
Resident
Other areas of specialty/work
Street address
Ghaem Hospital-Ahmad Abad Avenue
City
Mashhad
Postal code
Phone
+98 51 3840 9611
Fax
Email
aghaeea911@mums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr.Seyed Rasool Zakavi
Position
Professor
Other areas of specialty/work
Street address
Ghaem Hospital; Ahmad Abad Avenue
City
Mashhad
Postal code
Phone
+98 915 110 7844
Fax
Email
zakavir@mums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
dr.Athena Aghaee
Position
Resident of nuclear medicine
Other areas of specialty/work
Street address
Ahmad Abad Avenue ; Ghaem Hospital
City
Mashhad
Postal code
Phone
+98 51 3840 6911
Fax
+98 513840493
Email
aghaeea911@mums.ac.irs.soltani84@yahoo.com
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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