UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000046329 |
|---|---|
| Receipt number | R000052836 |
| Scientific Title | A Study on Improvement of Internal Dose Assessment Methods for Patients due to Inhalation of Radioactive Materials in Nuclear Disaster |
| Date of disclosure of the study information | 2021/12/13 |
| Last modified on | 2023/06/12 06:08:29 |
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Basic information
Public title
A Study on Improvement of Internal Dose Assessment Methods for Patients due to Inhalation of Radioactive Materials in Nuclear Disaster
Acronym
A Study on Improvement of Internal Dose Assessment Methods for Patients due to Inhalation of Radioactive Materials in Nuclear Disaster
Scientific Title
A Study on Improvement of Internal Dose Assessment Methods for Patients due to Inhalation of Radioactive Materials in Nuclear Disaster
Scientific Title:Acronym
A Study on Improvement of Internal Dose Assessment Methods for Patients due to Inhalation of Radioactive Materials in Nuclear Disaster
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study is to develop a rapid and accurate method for dose assessment of internally exposed patients, which will contribute to the maintenance and improvement of nuclear disaster medical functions, by developing 1) a rapid bioassay method and 2) a highly accurate in vivo measurement method using healthy volunteers as research subjects.
Basic objectives2
Others
Basic objectives -Others
(A) Expediting bioassay analysis
(1) Urine and stool samples are collected by research subjects at NIRS. A known amount of the tracer isotope is added to the collected bio-assay samples (urine and stool), and radiochemical analysis is performed. Then, the ratio of the amount of radioactivity obtained by the measurement to the radioactivity of the tracer isotope added to the sample (urine or stool) is derived as the recovery rate, and the rapidity, simplicity, and efficiency of the method are evaluated.
(B) Development of the in vitro measurement method for improving the measurement accuracy
The integrated in-vivo measurement system installed in the NIRS Advanced Radiation Dosimetry Facility will be used to measure the radioactivity of the background components of the research subjects under the assumption of actual use. By analyzing the wave height distribution obtained from the measurement, we will obtain the minimum detectable concentration of radioactive cesium, etc.
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
(A) recovery ratios of 223U, 242Pu, 243Am and 90Sr added to bio-assay samples
(2) Minimum detectable radio-activities of 137Cs, 134Cs and 131I in whole body derived from measurement using the whole body counter
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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
A healthy person capable of giving consent for participation in this study and who can read and understand the consent document.
Key exclusion criteria
Persons who have been or may be found to have coerced a socially vulnerable person
Persons who have undergone a nuclear medicine examination within one month (within one week in the case of PET examination), or who have received or are receiving radiation therapy (internal radiation therapy).
Persons who are judged by the researcher of the research institution to be inappropriate for this research.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Munehiko |
| Middle name | |
| Last name | Kowatari |
Organization
National Institutes for Quantum Science and Technology
Division name
Dept. of Radiation Measurement and Dose Assessment, National Institute of Radiological Sciences
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
043-206-3029
kowatari.munehiko@qst.go.jp
Public contact
Name of contact person
| 1st name | Munehiko |
| Middle name | |
| Last name | Kowatari |
Organization
National Institutes for Quantum Science and Technology
Division name
Dept. of Radiation Measurement and Dose Assessment, National Institute of Radiological Sciences
Zip code
263-8555
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
TEL
043-206-3029
Homepage URL
kowatari.munehiko@qst.go.jp
Sponsor or person
Institute
National Institutes for Quantum Science and Technology
Institute
Department
Personal name
Funding Source
Organization
National Institutes for Quantum Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Clinical Research Review Committee
Address
4-9-1, Anagawa, Inage-ku, Chiba-shi, Chiba, Japan
Tel
043-206-4709
helsinki@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
国立研究開発法人量子科学技術研究開発機構
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 12 | Month | 13 | 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
Enrolling by invitation
Date of protocol fixation
| 2021 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 11 | Month | 12 | Day |
Anticipated trial start date
| 2022 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Measurements simulating the measurement of residual doses of radioactive materials in the body of emergency workers in the event of a nuclear disaster, etc., will be carried out on the research subjects using an integrated external measurement device. In addition, measurements using a standing type external measurement device will also be conducted for comparison.
Management information
Registered date
| 2021 | Year | 12 | Month | 09 | Day |
Last modified on
| 2023 | Year | 06 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052836
