UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	NSCLC FMISO-PET
Title of the study (Brief title)	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	Tohoru Shiga
Organization	Hokkaido University Hospital
Division name	Depertment of Nuclear Medicine
Address	N15W7, Kita-ku, Sapporo, Hokkaido, Japan, 0608638
TEL	011-706-5152
Email	tshiga@med.hokudai.ac.jp

Public contact
Name of contact person	Tohru Shiga
Organization	Hokkaido University
Division name	Depertment of Nuclear Medicine
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2013 Year 06 Month 25 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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