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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000010237
Receipt No. R000011983
Scientific Title Positron emission computed tomography (PET) with L-[11C] methionine
Date of disclosure of the study information 2013/03/14
Last modified on 2013/03/13

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Basic information
Public title Positron emission computed tomography (PET) with L-[11C] methionine
Acronym PET with methionine
Scientific Title Positron emission computed tomography (PET) with L-[11C] methionine
Scientific Title:Acronym PET with methionine
Region
Japan

Condition
Condition malignant tumor
Classification by specialty
Hematology and clinical oncology Surgery in general Gastrointestinal surgery
Hepato-biliary-pancreatic surgery Breast surgery Obsterics and gynecology
Pediatrics Dermatology Oto-rhino-laryngology
Orthopedics Urology Radiology
Oral surgery Neurosurgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To evaluate the usefulness of Positron emission tomography using L-[11C] methionin as contrasted with the result of 18 F-FDG PET inspection for diagnosis of various tumors, a heart muscle disease, morbidity evaluation, verification with reference to clinical course and pathologicall diagnosis.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The efficacy of diagnosis of various tumor and heart disease
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization 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
Medicine
Interventions/Control_1 methionin
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 patients with malignant tumor and heart disease
Key exclusion criteria -restless
-extremely poorer health
-pregnant and breast-feeding women
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Michiyasu Suzuki
Organization Yamaguchi University Hospital
Division name Department of Neurosurgery
Zip code
Address 1-1-1 Minami-kogushi, Ube, Yamaguchi
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Makoto Ideguchi
Organization Yamaguchi University School of Medicine
Division name Department of Neurosurgery
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Yamaguchi University School of Medicine
Institute
Department

Funding Source
Organization Department of Neurosurgery, Yamaguchi University School of Medicine
Organization
Division
Category of Funding Organization Other
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
2013 Year 03 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 Enrolling by invitation
Date of protocol fixation
2012 Year 11 Month 12 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2013 Year 03 Month 13 Day
Last modified on
2013 Year 03 Month 13 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011983

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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