UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010636 |
|---|---|
| Receipt number | 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 17:17:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
umeda@u-fukui.ac.jp
Sponsor or person
Institute
Third Department of Internal Medicine, Faculty of Medical Sciences, University of Fukui
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006008
