UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050062 |
|---|---|
| Receipt number | R000056943 |
| Scientific Title | Amino acid PET tracer study in the central nervous system |
| Date of disclosure of the study information | 2023/04/01 |
| Last modified on | 2023/01/10 01:14:31 |
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Basic information
Public title
Amino acid PET tracer study in the central nervous system
Acronym
Amino acid PET tracer study
Scientific Title
Amino acid PET tracer study in the central nervous system
Scientific Title:Acronym
Amino acid PET tracer study
Region
| Japan |
Condition
Condition
brain tumors, spinal cord tumors
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
For patients with suspected CNS tumors, amino acid tracer PET will be performed to predict malignancy and extract features suggesting genetic information. Amino acid tracer PET will be performed to assess the risk of recurrence for patients after radical resection.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Prediction of malignancy and postoperative recurrence
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
One preoperative PET scan. Postoperative PET scan early after surgery, and a few months later. Three or more PET scans will be performed if necessary.
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 suspected or diagnosed brain or spinal cord tumors.
Key exclusion criteria
Patients in extremely poor general condition (e.g., abnormal vital signs) who cannot be accompanied by the attending physician for imaging.
Pediatric patients whose attending physician or guardians is unable to accompany the patient for imaging.
Women who are pregnant and who want to continue their pregnancy.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Yuji |
| Middle name | |
| Last name | Nakamoto |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
6068507
Address
54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
075-751-3760
yfushimi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasutaka |
| Middle name | |
| Last name | Fushimi |
Organization
Kyoto University Graduate School of Medicine
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
6068507
Address
54 Shogoin Kawaharacho, Sakyoku, Kyoto
TEL
0757513760
Homepage URL
diag_rad@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University
Institute
Department
Personal name
Funding Source
Organization
JSPS
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
Kyoto University Graduate School and Faculty of Medicine, Ethics Committee
Address
Yoshida-Konoe-cho, Sakyo-ku, Kyoto 606-8501, JAPAN
Tel
075-753-4680
ethcom@kuhp.kyoto-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
| 2023 | Year | 04 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 04 | Month | 15 | Day |
Last follow-up date
| 2028 | 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
| 2023 | Year | 01 | Month | 17 | Day |
Last modified on
| 2023 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000056943
