UMIN-CTR Clinical Trial

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	Completed
Date of protocol fixation	2010 Year 08 Month 11 Day
Date of IRB	2010 Year 09 Month 08 Day
Anticipated trial start date	2010 Year 09 Month 13 Day
Last follow-up date	2015 Year 07 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	2010 Year 09 Month 14 Day
Last modified on	2020 Year 03 Month 23 Day

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