UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061097 |
|---|---|
| Receipt number | R000069912 |
| Scientific Title | Investigation of the Pathophysiology of Pancreatic and Brain Tumors Using Carbon-11-Labeled Methyl-Leucine PET |
| Date of disclosure of the study information | 2026/03/29 |
| Last modified on | 2026/03/29 12:44:35 |
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Basic information
Public title
Investigation of the Pathophysiology of Pancreatic and Brain Tumors Using Carbon-11-Labeled Methyl-Leucine PET
Acronym
Investigation of the Pathophysiology of Pancreatic and Brain Tumors Using Carbon-11-Labeled Methyl-Leucine PET
Scientific Title
Investigation of the Pathophysiology of Pancreatic and Brain Tumors Using Carbon-11-Labeled Methyl-Leucine PET
Scientific Title:Acronym
Investigation of the Pathophysiology of Pancreatic and Brain Tumors Using Carbon-11-Labeled Methyl-Leucine PET
Region
| Japan |
Condition
Condition
pancreatic and brain tumors
Classification by specialty
| Hepato-biliary-pancreatic medicine | Neurology | Geriatrics |
| Hepato-biliary-pancreatic surgery | Psychiatry | Radiology |
| Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Patients with pancreatic or brain tumors, or suspected tumors will undergo carbon-11-labeled methyl-leucine PET imaging for the visualization of amino acid metabolism and the pathophysiological mechanisms of these tumors will be assessed based on tracer uptake.
Basic objectives2
Others
Basic objectives -Others
pathophysiological mechanism
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
carbon-11-labeled methyl-leucine uptake quantified as the standardized uptake value
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
Carbon-11-labeled methyl-leucine will be intravenously administered at a dose of 5-10 MBq/kg and PET/CT imaging of the lesion will be performed for 20 minutes between 15 and 60 minutes after injection.
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
patients with pancreatic or brain tumors or suspected tumors
Key exclusion criteria
Participants meeting any of the following criteria will be excluded:
Patients who are pregnant or may be pregnant
Patients with an urgent and life-threatening condition
Patients deemed unsuitable for the study by the investigator
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | Yoshihiro |
| Middle name | |
| Last name | nishiyama |
Organization
Faculty of Medicine, Kagawa University
Division name
Radiology
Zip code
761-0793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-898-5111
yamamoto.yuka@kagawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Yuka |
| Middle name | |
| Last name | yamamoto |
Organization
Faculty of Medicine, Kagawa University
Division name
Radiology
Zip code
7610793
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
TEL
087-898-5111
Homepage URL
yamamoto.yuka@kagawa-u.ac.jp
Sponsor or person
Institute
Kagawa University
Institute
Department
Personal name
Funding Source
Organization
Kagawa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Faculty of Medicine, Kagawa University
Address
1750-1 Ikenobe, Miki-cho, Kita-gun, Kagawa
Tel
087-898-5111
yamamoto.yuka@kagawa-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
| 2026 | Year | 03 | Month | 29 | 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 | 03 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2031 | 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
| 2026 | Year | 03 | Month | 29 | Day |
Last modified on
| 2026 | Year | 03 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069912
