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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000018670
Receipt No. R000021594
Scientific Title A study on differential diagnosis of radiation necrosis and brain tumor recurrence with dual stage Methionine PET/CT
Date of disclosure of the study information 2015/08/14
Last modified on 2018/03/31

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Basic information
Public title A study on differential diagnosis of radiation necrosis and brain tumor recurrence with dual stage Methionine PET/CT
Acronym Dual stage Methionine PET/CT
Scientific Title A study on differential diagnosis of radiation necrosis and brain tumor recurrence with dual stage Methionine PET/CT
Scientific Title:Acronym Dual stage Methionine PET/CT
Region
Japan

Condition
Condition brain tumor recurrence and radiation necrosis
Classification by specialty
Neurology Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To make accuracy, sensitivity, specificity higher by adding delayed image of methionine PET.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Which is more accurate, the conclusion from early image only and the conclusion from both early image and delayed image are compared.
The answer is acquired by the course or the pathology.
Key secondary outcomes

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 patients who undergoes methionine PET/CT to determine whether radiation necrosis or brain tumor recurrence
Key exclusion criteria patients who do not agree to participate
patients who have difficulty in stopping moving
other patients whom researcher (doctor) judged to exclude.
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masashi Kameyama
Organization National Center for Global Health and Medicine
Division name Division of Nuclear Medicine
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan, 162-8655
TEL 03-5273-6881
Email kame-tky@umin.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masashi Kameyama
Organization National Center for Global Health and Medicine
Division name Division of Nuclear Medicine
Zip code
Address 1-21-1 Toyama, Shinjuku-ku, Tokyo, Japan, 162-8655
TEL 03-5273-6881
Homepage URL
Email kame-tky@umin.ac.jp

Sponsor
Institute National Center for Global Health and Medicine
Institute
Department

Funding Source
Organization National Center for Global Health and Medicine
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
Address
Tel
Email

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
2015 Year 08 Month 14 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 Completed
Date of protocol fixation
2014 Year 10 Month 14 Day
Date of IRB
Anticipated trial start date
2014 Year 10 Month 14 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information under observation

Management information
Registered date
2015 Year 08 Month 14 Day
Last modified on
2018 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021594

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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