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UMIN ID:

Recruitment status Main results already published
Unique ID issued by UMIN UMIN000023327
Receipt No. R000026879
Scientific Title The retrospective study of the correlation between I-123 uptakes and iodine concentrations of thyroid glands for patients with hyperthyroidism
Date of disclosure of the study information 2016/08/01
Last modified on 2021/03/25

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Basic information
Public title The retrospective study of the correlation between I-123 uptakes and iodine concentrations of thyroid glands for patients with hyperthyroidism
Acronym The retrospective study of the correlation between I-123 uptakes and iodine concentrations of thyroid glands for patients with hyperthyroidism
Scientific Title The retrospective study of the correlation between I-123 uptakes and iodine concentrations of thyroid glands for patients with hyperthyroidism
Scientific Title:Acronym The retrospective study of the correlation between I-123 uptakes and iodine concentrations of thyroid glands for patients with hyperthyroidism
Region
Japan

Condition
Condition Hyperthyroidism
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The aim of this study is to evaluate the correlation between I-123 uptakes in thyroid glands and iodine concentration calculated by DECT. We investigate whether DECT can assess thyroid function in patients with hyperthyroidism.
Basic objectives2 Others
Basic objectives -Others A novel method for evaluation of thyroid function
Trial characteristics_1 Confirmatory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes Two examinations about thyroid function, including I-123 uptake and iodine concentrations by DECT, will reveal turnover of thyroid glands with two different aspects; 1) increasing uptake and 2) increasing excretion. DECT can predict thyroid function to evaluate excretion of iodine.
Key secondary outcomes

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
24 years-old <
Age-upper limit
79 years-old >
Gender Female
Key inclusion criteria - Patients with hyperthyroidism
- Treatment of I-131 ablation therapy
- Both I-123 scintigraphy and DECT before treatment
Key exclusion criteria Inadequate iodine regulated diet
No scintigraphy nor DECT
Target sample size 13

Research contact person
Name of lead principal investigator
1st name Nakajima
Middle name
Last name Takahito
Organization Gunma Graduate School of Medicine
Division name Molecular Imaging Division
Zip code 3718911
Address 3-39-22, Showa, Maebashi, Gunma, Japan
TEL 027-220-8401
Email sojin@gunma-u.ac.jp

Public contact
Name of contact person
1st name Nakajima
Middle name
Last name Takahito
Organization Gunma University Hospital
Division name Diagnostic radiology and nuclear medicine
Zip code 3718911
Address 3-39-22, Showa, Maebashi, Gunma, Japan
TEL 027-220-8401
Homepage URL
Email sojin@gunma-u.ac.jp

Sponsor
Institute Gunma University
Institute
Department

Funding Source
Organization Japan Science and Technology
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Gunma Graduate School of Medicine
Address 3-39-22, Showa, Maebashi, Gunma, Japan
Tel +81272208401
Email sojin@gunma-u.ac.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 群馬大学医学部附属病院(群馬県)

Other administrative information
Date of disclosure of the study information
2016 Year 08 Month 01 Day

Related information
URL releasing protocol men
Publication of results Published

Result
URL related to results and publications https://bmcmedimaging.biomedcentral.com/articles/10.1186/s12880-017-0216-6
Number of participants that the trial has enrolled 13
Results Iodine concentration calculated by DECT can predict thyroid function.
Results date posted
2021 Year 03 Month 25 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics a. Graves' disease or hyperthyroid patients with a strong suspicion of Graves' disease
b. iodine restricted diet for more than 2 weeks before iodine ablation therapy
Participant flow retrospective study
Adverse events n.a.
Outcome measures The correlation of 123I uptakes with iodine concentration evaluated by DECT
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Main results already published
Date of protocol fixation
2016 Year 06 Month 17 Day
Date of IRB
2016 Year 07 Month 01 Day
Anticipated trial start date
2016 Year 08 Month 01 Day
Last follow-up date
2019 Year 07 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This study is published in BMC medical imaging.

Management information
Registered date
2016 Year 07 Month 25 Day
Last modified on
2021 Year 03 Month 25 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026879

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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