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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010636
Receipt No. R000006008
Scientific Title 18F-FLT and 18F-FDG PET imaging for patients with non-small cell lung cancer
Date of disclosure of the study information 2013/05/02
Last modified on 2019/08/10

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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

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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