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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004208
Receipt No. R000005057
Scientific Title The exploratory study of F-18 FAZA PET/CT for patients with non-small cell lung cancer
Date of disclosure of the study information 2010/09/15
Last modified on 2019/09/22

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Basic information
Public title The exploratory study of F-18 FAZA PET/CT for patients with non-small cell lung cancer
Acronym FAZA PET/CT tests for patients with lung cancer
Scientific Title The exploratory study of F-18 FAZA PET/CT for patients with non-small cell lung cancer
Scientific Title:Acronym FAZA PET/CT tests for patients with lung cancer
Region
Japan

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

Objectives
Narrative objectives1 To evaluate clinical usefulness of F-18 FAZA PET/CT for patients with primary non-small cell lung cancer who are scheduled to receive curative treatments.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The accumulation of FAZA at the tumor
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 F-18 FAZA PET/CT
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) The case who was diagnosed as primary non-small cell lung cancer either pathologically or cytologically.
2) The case whose primary lesion was no smaller than 1cm on CT images.
3) The case who was scheduled to receive a curative treatment such as surgery, radiation, chemotherapy and chemoradiotherapy.
4) The case to whom iodine contrast media can be injected.
5) The case who gave the written consent to join the study.
6) The case whose PS is between 0 and 2, the case who suffers from a serious illness except malignancy and the case who will become pregnant.
Key exclusion criteria 1) The case who is difficult to be included in the study due to psychological disorder and so on.
2) The case to whom the test agent cannot be injected due to iodine allergy and so on.
3) The case who is judged by the physician in charge not to be included in the study.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name HIROFUMI
Middle name
Last name FUJII
Organization National Cancer Center Hospital East
Division name Functional Imaging Division
Zip code 277-8577
Address 6-5-1 Kashiwanoha, Kashiwa
TEL 04-7134-6831
Email fujii-rad@umin.org

Public contact
Name of contact person
1st name Hirofumi
Middle name
Last name Fujii
Organization National Cancer Center Hospital East
Division name Functional Imaging Division
Zip code 277-8577
Address 6-5-1 Kashiwanoha, Kashiwa
TEL 04-7134-6831
Homepage URL
Email fujii-rad@umin.org

Sponsor
Institute National Cancer Center
Institute
Department

Funding Source
Organization The Health and Labor Sciences Research Grants for Third Term Comprehensive 10-year Strategy for Cancer Control
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Office for Research Ethics, National Cancer Center
Address 5-1-1 Tsukiji, Chuo-ku, Tokyo 104-0045
Tel 03-3542-2511
Email NCC@IRBofficeml.res.ncc.go.jp

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
2010 Year 09 Month 15 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 No longer recruiting
Date of protocol fixation
2010 Year 08 Month 11 Day
Date of IRB
Anticipated trial start date
2010 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 14 Day
Last modified on
2019 Year 09 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005057

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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