UMIN-CTR Clinical Trial

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

Medicak examination receiver or chronically ill individual

Classification by specialty

Child

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

National Institutes for Quantum and Radiological Science and Technology

Institute

Department

Personal name

Organization

National Institutes for Quantum and Radiological Science and Technology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Co-sponsor

Self-defense forces central hospital

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2020

Year

11

Month

05

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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

Registered date

2020

Year

11

Month

04

Day

Last modified on

2020

Year

11

Month

05

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048330