UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061430 |
|---|---|
| Receipt number | R000070182 |
| Scientific Title | A quantitative pharmacokinetic analysis of [18F]BCPP-EF in abdominal organs |
| Date of disclosure of the study information | 2026/05/11 |
| Last modified on | 2026/05/01 10:17:47 |
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Basic information
Public title
Quantitative pharmacokinetic analysis of [18F]BCPP-EF in abdominal organs
Acronym
Quantitative pharmacokinetics of [18F]BCPP-EF
Scientific Title
A quantitative pharmacokinetic analysis of [18F]BCPP-EF in abdominal organs
Scientific Title:Acronym
BCPP-EF PK
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Hepato-biliary-pancreatic medicine | Nephrology | Radiology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To estimate pharmacokinetic parameters related to MC-I binding of [18F]BCPP-EF in abdominal organs using compartment model analysis and to compare parametric images with semiquantitative tracer uptake images.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Correlation between [18F]BCPP-EF parametric images (including distribution volume) obtained from compartment model analysis and semiquantitative tracer uptake images.
Key secondary outcomes
Correlations between clinical, hematological, and imaging parameters
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
| Other |
Interventions/Control_1
Blood sampling, intravenous PET tracer injection, CT imaging, and PET imaging
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
(1) Individuals who are => 20 years old and < 70 years old at the time of informed consent acquisition
(2) Individuals without a psychiatric or neurological history
(3) Individuals without a smoking history
(4) Individuals without alcoholics
(5) Individuals not taking regular medicines
(6) Capability of written informed consent based on their own decision
Key exclusion criteria
(1) Healthy subjects who have participated in another nuclear medicine study within the past year.
(2) Pregnant, possibly pregnant or lactating women
(3) Others judged inappropriate for the study by the investigator(s).
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Yasuomi |
| Middle name | |
| Last name | Ouchi |
Organization
Hamamatsu Medical Photonics Foundation
Division name
Hamamatsu Medical Imaging Center
Zip code
434-0041
Address
5000, Hirakuchi, Hamana-ku, Hamamatsu City, Shizuoka, Japan
TEL
053-584-6411
ouchi@hmp.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Ohba |
Organization
Hamamatsu Photonics K.K.
Division name
Central Research Laboratory
Zip code
434-8601
Address
5000, Hirakuchi, Hamana-ku, Hamamatsu City, Shizuoka, Japan
TEL
053-586-7111
Homepage URL
h-ohba@crl.hpk.co.jp
Sponsor or person
Institute
Hamamatsu Medical Photonics Foundation
Institute
Department
Personal name
Funding Source
Organization
Hamamatsu Photonics K.K.
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
Hamamatsu Medical Photonics Foundation
Address
5000, Hirakuchi, Hamana-ku, Hamamatsu City, Shizuoka, Japan
Tel
053-584-6411
takagi@hmp.or.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
| 2026 | Year | 05 | Month | 11 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 12 | Month | 18 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2028 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 05 | Month | 01 | Day |
Last modified on
| 2026 | Year | 05 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070182
