UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022667
Receipt number R000026117
Scientific Title Study on the reconstruction of I-131 measurements in the thyroid using individual numerical phantoms
Date of disclosure of the study information 2016/06/08
Last modified on 2018/07/24 18:18:40

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Basic information

Public title

Study on the reconstruction of I-131 measurements in the thyroid using individual numerical phantoms

Acronym

Study on the reconstruction of I-131 measurements in the thyroid using individual numerical phantoms

Scientific Title

Study on the reconstruction of I-131 measurements in the thyroid using individual numerical phantoms

Scientific Title:Acronym

Study on the reconstruction of I-131 measurements in the thyroid using individual numerical phantoms

Region

Japan


Condition

Condition

Persons who had accidental intake of radionuclides

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To improve the accuracy of internal dose estimations using numerical phantoms

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Comparison in the detector's response between numerical phantoms and a physical phantom

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

MRI photography

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

20 years-old <=

Age-upper limit


Not applicable

Gender

Male

Key inclusion criteria

Nuclear power plant workers whose effective doses are expected to be 250 mSv or higher

Key exclusion criteria

Persons with contraindication to MRI examinations

Target sample size

7


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Osamu Kurihara

Organization

National Institute for Quantum and Radiological Institute of Radiological Science and Technology

Division name

Dept. of Radiation Measurement and Dose Assessment

Zip code


Address

4-9-1 Anagawa, Inage-ku, Chiba-city, CHIBA

TEL

043-206-4734

Email

kurihara.osamu@qst.go.jp


Public contact

Name of contact person

1st name
Middle name
Last name Osamu Kurihara

Organization

National Institute for Quantum and Radiological Institute of Radiological Science and Technology

Division name

Dept. of Radiation Measurement and Dose Assessment

Zip code


Address

4-9-1 Anagawa, Inage-ku, Chiba-city, CHIBA 263-8555 Japan

TEL

043-206-4734

Homepage URL


Email

kurihara.osamu@qst.go.jp


Sponsor or person

Institute

National Institute for Quantum and Radiological Institute of Radiological Science and Technology

Institute

Department

Personal name



Funding Source

Organization

National Institute for Quantum and Radiological Institute of Radiological Science and Technology

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization


Address


Tel


Email



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

2016 Year 06 Month 08 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

Completed

Date of protocol fixation

2016 Year 06 Month 01 Day

Date of IRB


Anticipated trial start date

2016 Year 06 Month 01 Day

Last follow-up date


Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2016 Year 06 Month 08 Day

Last modified on

2018 Year 07 Month 24 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026117


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name