UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000042213
Receipt No. 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 2020/10/22

* 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
Email 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
Email asakata@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Graduate School of Medicine
Institute
Department

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
Email ctsodan@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
2020 Year 10 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048190

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.