UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A pilot study for effective evaluations of FLT-PET in the effect of stereotactic radiotherapy on non-small-cell lung cancer
Title of the study (Brief title)	A pilot study for effective evaluations of FLT-PET in the effect of stereotactic radiotherapy on non-small-cell lung
Region	Japan

Condition
Condition	Non-small-cell lung cancer
Classification by specialty	Pneumology Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	Pilot study of the effectiveness of FLT-PET in the effect judgment of SRT on non-small-cell lung cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	Effect of SRT on non-small-cell lung cancer
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 Device,equipment
Interventions/Control_1	FLT-PET
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)Good general condition 2)Patient with non small cell lung cancer of adaptation of SRT 3)The patient who plans SRT and follow-up in FBRI 4)Patiant who is performed FDG-EPT/CT before treatment, or planned FDG-EPT/CT in a few days in FBRI 5)Patiant who can understand study contents, and obtain written consent
Key exclusion criteria	1)Patient who cannot keep supine position for 30 minutes 2) Patient who is pregnant or the possibility of pregnancy 3) Patient who is severe claustrophobia 4) Patient who is regarded as unsuitable by responsible investigators
Target sample size	2

Research contact person
Name of lead principal investigator	Michio Senda
Organization	Institute of Biomedical Research and Innovation
Division name	Division of Molecular Imaging
Address	2-2, Minatojima-Minamimachi, Chuo-ku, Kobe
TEL	078-304-5212
Email	senda@fbri.org

Public contact
Name of contact person	Akihito Ohnishi
Organization	Institute of Biomedical Research and Innovation
Division name	Division of Molecular Imaging
Address	2-2, Minatojima-Minamimachi, Chuo-ku, Kobe
TEL	078-304-5212
Homepage URL
Email	ohnishi@fbri.org

Sponsor
Institute	Foundation of Biomedical Research and Innovation
Institute
Department

Funding Source
Organization	Foundation of Biomedical Research and Innovation
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

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	先端医療センター（兵庫県）

Other administrative information
Date of disclosure of the study information	2015 Year 02 Month 09 Day

Progress
Recruitment status	Terminated
Date of protocol fixation	2012 Year 09 Month 30 Day
Anticipated trial start date	2012 Year 10 Month 01 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 02 Month 09 Day
Last modified on	2016 Year 08 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010402