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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036478
Receipt No. R000041567
Scientific Title Evaluation of LAT1 expression by FBPA PET
Date of disclosure of the study information 2019/05/01
Last modified on 2019/08/16

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Basic information
Public title Evaluation of L-type amino acid transporter 1 (LAT1) expression by F-18 FBPA PET
Acronym FBPA-PET
Scientific Title Evaluation of LAT1 expression by FBPA PET
Scientific Title:Acronym FBPA-LAT1
Region
Japan

Condition
Condition Malignant tumor
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 The expression of L-type amino acid transporter 1 (LAT1) is estimated from the degree of accumulation on the FBPA-PET image.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The whole body distribution is evaluated using PET-CT, and the uptake in the tumor is quantitatively measured.
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
Medicine
Interventions/Control_1 PET drug administration
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Targets patients who have been clinically diagnosed with malignancy.
Key exclusion criteria 1. a pregnant and lactating subject or a person who wishes to become pregnant
2. Pediatric patients who need sedation
3. Others who are judged inappropriate
Target sample size 50

Research contact person
Name of lead principal investigator
1st name Tadashi
Middle name
Last name Watabe
Organization Osaka University Graduate School of Medicine
Division name Department of Nuclear Medicine and Tracer Kinetics
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka, 565-0871, JAPAN
TEL 06-6879-3461
Email watabe@tracer.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Tadashi
Middle name
Last name Watabe
Organization Osaka University Graduate School of Medicine
Division name Department of Nuclear Medicine and Tracer Kinetics
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka, 565-0871, JAPAN
TEL 06-6879-3461
Homepage URL
Email watabe@tracer.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization MEXT
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 Osaka University School of Medicine Hospital Clinical Research Center for Future Medicine
Address 2-2 Yamadaoka, Suita, Osaka, 565-0871, JAPAN
Tel 06-6210-8296
Email rinri@hp-crc.med.osaka-u.ac.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
2019 Year 05 Month 01 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
2019 Year 04 Month 11 Day
Date of IRB
2019 Year 05 Month 10 Day
Anticipated trial start date
2019 Year 05 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 04 Month 11 Day
Last modified on
2019 Year 08 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041567

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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