UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023327 |
|---|---|
| Receipt number | 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 09:15:42 |
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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
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
sojin@gunma-u.ac.jp
Sponsor or person
Institute
Gunma University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026879
