UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042213 |
|---|---|
| Receipt number | R000048190 |
| Scientific Title | hypoxic imaging for brain tumor with 18F-fluoromisonidazole PET |
| Date of disclosure of the study information | 2020/12/01 |
| Last modified on | 2022/04/25 10:42:01 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
hypoxic imaging for brain tumor with 18F-fluoromisonidazole PET
Acronym
FMISO-PET for brain tumor
Scientific Title
hypoxic imaging for brain tumor with 18F-fluoromisonidazole PET
Scientific Title:Acronym
FMISO-PET for brain tumor
Region
| Japan |
Condition
Condition
brain tumor
Classification by specialty
| Radiology | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To visualize hypoxic area in brain tumors with FMISO-PET
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
diagnostic performance
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
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Acquisition of 18F-fluoromisonidazole PET with PET/CT or PET/MRI
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients suspected to have brain tumors
Key exclusion criteria
(1) unstable patients
(2) pediatric patients without their caregivers
(3) pregnant patients in her 1st trimester
Target sample size
170
Research contact person
Name of lead principal investigator
| 1st name | Yasutaka |
| Middle name | |
| Last name | Fushimi |
Organization
Kyoto University Hospital
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
6068507
Address
Shogoin-Kawahara cho 54 Sakyo-ku Kyoto
TEL
0757513760
yfushimi@kuhp.kyoto-u.ac.jp
Public contact
Name of contact person
| 1st name | Akihiko |
| Middle name | |
| Last name | Sakata |
Organization
Kyoto University Hospital
Division name
Department of Diagnostic Imaging and Nuclear Medicine
Zip code
6068507
Address
Shogoin-Kawahara cho 54 Sakyo-ku Kyoto
TEL
0757513760
Homepage URL
asakata@kuhp.kyoto-u.ac.jp
Sponsor or person
Institute
Kyoto University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
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 Hospital
Address
Shogoin-Kawahara cho 54 Sakyo-ku Kyoto
Tel
0757514748
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
京都大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | 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
| 2020 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2026 | Year | 11 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 22 | Day |
Last modified on
| 2022 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048190
