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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017184
Receipt No. R000019937
Scientific Title NSCLC FMISO-PET
Date of disclosure of the study information 2015/04/21
Last modified on 2018/11/06

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Basic information
Public title NSCLC FMISO-PET
Acronym NSCLC FMISO-PET
Scientific Title NSCLC FMISO-PET
Scientific Title:Acronym NSCLC FMISO-PET
Region
Japan

Condition
Condition NSCLC
Classification by specialty
Pneumology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Usefulness of FMISO-PET
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes FMISO-PET
SUV
Tumor/blood ratio
Tumor/muscle ratio
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 date:6/2013 - 3/2018
doze:400MBq
frequency:1-2
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 1.20 years old or older
2.lung carcinoma
3.Document agreement by the free will of the person
Key exclusion criteria 1.Face up position rest
2.pregnant and parturient women
3.Inadequacy and judgment
Target sample size 45

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tohoru Shiga
Organization Hokkaido University Hospital
Division name Depertment of Nuclear Medicine
Zip code
Address N15W7, Kita-ku, Sapporo, Hokkaido, Japan, 0608638
TEL 011-706-5152
Email tshiga@med.hokudai.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tohru Shiga
Organization Hokkaido University
Division name Depertment of Nuclear Medicine
Zip code
Address N15W7, Kita-ku, Sapporo, Hokkaido, Japan, 0608638
TEL 011-706-5152
Homepage URL
Email tshiga@med.hokudai.ac.jp

Sponsor
Institute Hokkaido University Hospital
Institute
Department

Funding Source
Organization Hokkaido University
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
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 04 Month 21 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
2013 Year 06 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 06 Month 30 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
2015 Year 04 Month 20 Day
Last modified on
2018 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019937

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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