UMIN-CTR Clinical Trial

Basic information
Public title	Study on improvement of internal thyroid exposure examination method for newborns to children
Acronym	Study on improvement of internal thyroid exposure examination method for newborns to children
Scientific Title	Study on improvement of internal thyroid exposure examination method for newborns to children
Scientific Title:Acronym	Study on improvement of internal thyroid exposure examination method for newborns to children
Region	Japan

Condition
Condition	Medicak examination receiver or chronically ill individual
Classification by specialty	Child
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of measurement method by new thyroid monitor and improvement of internal exposure measurement method in the event of a nuclear disaster
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Development of measurement method by new thyroid monitor and proposal of internal exposure measurement method in the event of a nuclear disaster
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	28 days-old <=
Age-upper limit	70 years-old >=
Gender	Male and Female
Key inclusion criteria	Medical examination receiver or chronically ill individual 1. Newborans(28days-old) to children under 12 years old 2. Parents or guardians who are relatives of 1
Key exclusion criteria	1. Individuals who have undergone a nuclear medicine examination (PET / CT examination) within one week 2. Individuals who have undergone nuclear medicine examinations (heart, bone scintigraphy, etc.) excluding PET / CT examinations within one month 3. Individuals who have or have received radiation therapy (internal radiation therapy) in the past 4. Individuals living with relatives who have undergone nuclear medicine examinations and radiation therapy 5. Individuals who are judged by the researchers of the research institution to be inappropriate for this research
Target sample size	140

Research contact person
Name of lead principal investigator	1st name Osamu Middle name Last name Kurihara
Organization	National Institutes for Quantum and Radiological Science and Technology
Division name	Department of Radiation Measurement and Dose Assessment
Zip code	263-8555
Address	4-9-1 Anagawa Inage-ku Chiba 263-8555 JAPAN
TEL	043-206-4734
Email	kurihara.osamu@qst.go.jp

Public contact
Name of contact person	1st name Osamu Middle name Last name Kurihara
Organization	National Institutes for Quantum and Radiological Science and Technology
Division name	Department of Radiation Measurement and Dose Assessment
Zip code	263-8555
Address	4-9-1 Anagawa Inage-ku Chiba 263-8555 JAPAN
TEL	043-206-4734
Homepage URL
Email	kurihara.osamu@qst.go.jp

Sponsor
Institute	National Institutes for Quantum and Radiological Science and Technology
Institute
Department

Funding Source
Organization	National Institutes for Quantum and Radiological Science and Technology
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	Self-defense forces central hospital
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Institutes for Quantum and Radiological Science and Technology
Address	4-9-1 Anagawa Inage-ku Chiba 263-8555 JAPAN
Tel	043-206-4734
Email	kurihara.osamu@qst.go.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

Other administrative information
Date of disclosure of the study information	2020 Year 11 Month 05 Day

Related information
URL releasing protocol
Publication of results	Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2020 Year 09 Month 30 Day
Date of IRB
Anticipated trial start date	2020 Year 11 Month 11 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other

Other related information

Methods 1. Examination of thyroid measurement posture using new thyroid monitor 1-1. Measurement posture at each age:In the state of being held by the research subject (substitute), or in the supine or sitting position, etc.) 1-2. Measurement time (Max. 180sec) 1-3. Distance from thyroid monitor to neck surface during measurement 2. Collection of basic information of research subjects (Age, gender, height, weight, neck height, neck width, neck circumference, etc.) 3. Questionnaire on basic knowledge of radiation exposure, recognition / understanding of thyroid dose measurement, and new thyroid monitor for research subjects

Management information
Registered date	2020 Year 11 Month 04 Day
Last modified on	2020 Year 11 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048330