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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000042984
Receipt No. R000049071
Scientific Title Diagnostic accuracy of intracranial lesion using 11C-Methionine PET/CT
Date of disclosure of the study information 2021/01/13
Last modified on 2021/01/13

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Basic information
Public title Diagnostic accuracy of intracranial lesion using 11C-Methionine PET/CT
Acronym Diagnostic accuracy using METPET/CT for intracranial lesion
Scientific Title Diagnostic accuracy of intracranial lesion using 11C-Methionine PET/CT
Scientific Title:Acronym Diagnostic accuracy using METPET/CT for intracranial lesion
Region
Japan

Condition
Condition Brain tumor
Classification by specialty
Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To compare the final diagnosis and pre-treatment radiological diagnosis of 11C-Methionine PET/CT in multicenter retrospective study
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Final diagnosis
Key secondary outcomes Maximum diameter, Shape, Lesion/normal ratio, Number, Area

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 The subjects who were taken 11C-Methionine PET/CT before treatment between April 1, 2017 and August 31, 2020. The final clinical diagnosis is mandatory.
Key exclusion criteria 1.Subjects who have no final clinical diagnosis.
2.Subjects who cannot provide informed consent.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name Yoshinori
Middle name
Last name Higuchi
Organization Chiba University Graduate School of Medicine
Division name Department of Neurological Surgery
Zip code 260-8670
Address 1-8-1 Inohana, Chuo-ku, Chiba city, Chiba, Japan
TEL 043-226-2158
Email yhiguchi@faculty.chiba-u.jp

Public contact
Name of contact person
1st name Tomohiro
Middle name
Last name Yamaki
Organization Rehabilitation Center for Traumatic Apallics Chiba
Division name Neurosurgery & PET imaging division
Zip code 261-0012
Address 3-30-1 Isobe, Mihama-ku, Chiba-city, Chiba, Japan
TEL 043-277-0061
Homepage URL
Email t-yamaki@chiba-ryougo.jp

Sponsor
Institute Rehabilitation Center for Traumatic Apallics Chiba
Institute
Department

Funding Source
Organization Rehabilitation Center for Traumatic Apallics Chiba
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 Rehabilitation Center for Traumatic Apallics Chiba
Address 3-30-1 Isobe, Mihama-ku, Chiba-city, Chiba, Japan
Tel 043-277-0061
Email takahito-seki@chiba-ryougo.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
2021 Year 01 Month 13 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 Enrolling by invitation
Date of protocol fixation
2020 Year 12 Month 16 Day
Date of IRB
2020 Year 12 Month 16 Day
Anticipated trial start date
2021 Year 01 Month 01 Day
Last follow-up date
2023 Year 12 Month 13 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information Retrospective study

Management information
Registered date
2021 Year 01 Month 13 Day
Last modified on
2021 Year 01 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049071

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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