UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014572 |
|---|---|
| Receipt number | R000016939 |
| Scientific Title | Hypoxia imaging with 18F-Misonidazole PET in brain metastasis |
| Date of disclosure of the study information | 2014/07/22 |
| Last modified on | 2024/01/22 11:38:04 |
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Basic information
Public title
Hypoxia imaging with 18F-Misonidazole PET in brain metastasis
Acronym
Hypoxia imaging with FMISO PET in brain metastasis
Scientific Title
Hypoxia imaging with 18F-Misonidazole PET in brain metastasis
Scientific Title:Acronym
Hypoxia imaging with FMISO PET in brain metastasis
Region
| Japan |
Condition
Condition
metastatic brain tumor
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To verify whether it is possible to evaluate hypoxia evaluation for matastatic brain tumor
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
SUV(Standardized Uptake Value),lesion to cerebellum ratio,Tumor/blood ratio
Key secondary outcomes
local control survival rate, overall survival rate
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
| Device,equipment |
Interventions/Control_1
FMISO 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1)metastatic brain tumor whose maximum diameter is equal to or above 5mm in MRI.
2)no treatment history with radiotherapy or surgery to metastatic brain tumor.
3)no meningitis carcinomatosa and dissemination in MRI.
4)KPS equal to or above 70%.
5)Pathologically (histologically or cytologically) proven diagnosis from extra cranial lesion.
6)Patients must sign a study-specific informed consent prior to study entry.
Key exclusion criteria
1)patient who can rest in dorsal position for about one hour
2)patient with severe claustrophobia
3)nonage
4)expectant and nursing mothers
5)patient judged unsuitable as a trial subject by the principal investigator
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Takashi |
| Middle name | |
| Last name | Mori |
Organization
Hokkaido University Hospital
Division name
Department of Radiation Oncology
Zip code
060-8638
Address
Kita 15-jo Nishi 7-chome, Kita-ku, Sapporo,Hokkaido
TEL
011-706-5977
huvrad-secretary@rad.med.hokudai.ac.jp
Public contact
Name of contact person
| 1st name | Takashi |
| Middle name | |
| Last name | Mori |
Organization
Hokkaido University Hospital
Division name
Department of Radiation Oncology
Zip code
060-8638
Address
Kita 15-jo Nishi 7-chome, Kita-ku, Sapporo,Hokkaido
TEL
011-706-5977
Homepage URL
tamori-tym@umin.ac.jp
Sponsor or person
Institute
Departments of Radiation Oncology, Hokkaido University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Radiation Medicine Hokkaido University Graduate School of Medicine
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
Clinical Research and Medical Innovation Center
Address
Kita 14, Nishi 5, Kita-ku, Sapporo, Hokkaido, 060-8648 Japan
Tel
011-706-7061
crmoni@pop.med.hokudai.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
| 2014 | Year | 07 | Month | 22 | 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
25
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
Completed
Date of protocol fixation
| 2014 | Year | 08 | Month | 22 | Day |
Date of IRB
| 2014 | Year | 08 | Month | 22 | Day |
Anticipated trial start date
| 2014 | Year | 08 | Month | 22 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2023 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 07 | Month | 16 | Day |
Last modified on
| 2024 | Year | 01 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016939
