UMIN-CTR Clinical Trial

Basic information
Public title	18F-FLT and 18F-FDG PET imaging for patients with non-small cell lung cancer
Acronym	18F-FLT and 18F-FDG PET imaging for patients with non-small cell lung cancer
Scientific Title	18F-FLT and 18F-FDG PET imaging for patients with non-small cell lung cancer
Scientific Title:Acronym	18F-FLT and 18F-FDG PET imaging for patients with non-small cell lung cancer
Region	Japan

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

Objectives
Narrative objectives1	To clarify the efficacy of 18F-FLT and 18F-FDG PET imaging in patients with non-small cell lung cancer.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	Diagnostic accuracy of 18F-FLT and 18F-FDG PET
Key secondary outcomes	1, Overall survival after PET examination 2, Predictive value of 18F-FLT and 18F-FDG PET in patients with non-small cell lung cancer treated with systemic chemotherapy.

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	Device,equipment
Interventions/Control_1	Patients undergo both 18F-FLT and 18F-FDG PET scan before and after 1 cycle of systemic chemotherapy.
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	Eligible patients are men and women aged 20 years or older with a diagnosis of non-small cell carcinoma.
Key exclusion criteria	Exclusion criteria; 1, Fasting serum glucose levels above 150 mg/dl. 2, Pregnant women. 3, Nursing women.
Target sample size	80

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yukihiro Umeda
Organization	Faculty of Medical Sciences, University of Fukui
Division name	Third Department of Internal Medicine
Zip code
Address	23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL	0776-61-3111
Email	umeda@u-fukui.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yukihiro Umeda
Organization	Faculty of Medical Sciences, University of Fukui
Division name	Third Department of Internal Medicine
Zip code
Address	23-3, Matsuokashimoaizuki, Eiheiji-cho, Fukui, Japan
TEL	0776-61-3111
Homepage URL
Email	umeda@u-fukui.ac.jp

Sponsor
Institute	Third Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui
Institute
Department

Funding Source
Organization	Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Biomedical Imaging Research Center, Faculty of Medical Sciences, Universtity of Fukui
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	福井大学医学部附属病院（福井県）

Other administrative information
Date of disclosure of the study information	2013 Year 05 Month 02 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	2010 Year 06 Month 01 Day
Date of IRB	2010 Year 05 Month 19 Day
Anticipated trial start date	2010 Year 06 Month 24 Day
Last follow-up date	2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 05 Month 02 Day
Last modified on	2019 Year 08 Month 10 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006008