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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022850
Receipt No. R000026336
Scientific Title Estimation of 10B concentration in boron neutron capture therapy: potential of image-guided therapy using 18FBPA PET
Date of disclosure of the study information 2016/06/30
Last modified on 2016/06/23

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Basic information
Public title Estimation of 10B concentration in boron neutron capture therapy: potential of image-guided therapy using 18FBPA PET
Acronym Normal 10B concentration and 18FBPA PET
Scientific Title Estimation of 10B concentration in boron neutron capture therapy: potential of image-guided therapy using 18FBPA PET
Scientific Title:Acronym Normal 10B concentration and 18FBPA PET
Region
Japan

Condition
Condition Normal volunteer
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 In boron neutron capture therapy (BNCT) for cancer, the accurate estimation of 10B tissue concentrations, especially in neighboring normal organs, is important to avoid adverse effects. The 10B concentration in normal organs after loading with 10B, however, has not been established in humans. In this study, we performed 4-borono-2-[18F]-fluoro-phenylalanine (18FBPA) PET in healthy volunteers and estimated the chronological changes in the 10B concentrations of normal organs.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Estimation of 10B concentration in normal organs using 18FBPA PET.
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 Diagnosis
Type of intervention
Maneuver
Interventions/Control_1 Venous cannulation and injection of radioisotope.
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
70 years-old >=
Gender Male and Female
Key inclusion criteria Normal volunteers aged from 20 years-old to 70 years-old.
Key exclusion criteria 1. a pregnant woman and a subject nursing or person in hope of the pregnancy.
2. Person younger than 20 year.
3. in addition, the person who judged that it was inappropriate.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Jun Hatazawa
Organization Osaka University Graduate School of Medicine
Division name Department of Nuclear Medicine and Tracer Kinetics
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3461
Email hatazawa@tracer.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Eku Shimosegawa
Organization Osaka University Graduate School of Medicine
Division name Department of Molecular Imaging in Medicine
Zip code
Address 2-2 Yamadaoka, Suita, Osaka
TEL 06-6879-3767
Homepage URL
Email eku@mi.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization The Ministry of Education, Culture, Sports, Science and Technology, Japan.
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
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 30 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
2013 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2013 Year 07 Month 08 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 23 Day
Last modified on
2016 Year 06 Month 23 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026336

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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