UMIN-CTR Clinical Trial

Basic information
Public title	The study of hypoxia imaging using FAZA
Acronym	Hypoxia imaging with FAZA
Scientific Title	The study of hypoxia imaging using FAZA(1-(5-[18 F]Fluoro-5-deoxy-alpha-D-arabinofuranosyl)-2-nitroimidazole)
Scientific Title:Acronym	The study of hypoxia imaging using FAZA
Region	Japan

Condition
Condition	ischemic disease, malignant tumor
Classification by specialty	Medicine in general Surgery in general Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate clinical usefulness of hypoxia imaging using [F-18] FAZA PET/CT for patients with ischemic disease ore malignant tumors.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	the uptake of [F-18] FAZA in lesions
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	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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Assured for (F-18) FDG PET/CT, greater than or equal to 20 year of age with written informed consent
Key exclusion criteria	1.The case who is difficult to participate in the study due to psychological disorders and other diseases. 2.The case who is judged as inappropriate by the physician
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Ukihide Middle name Last name Tateishi
Organization	Medical Hospital Tokyo Medical and De ntal University
Division name	Department of Diagnostic Radiology
Zip code	1138519
Address	1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL	03-5803-5311
Email	ttisdrnm@tmd.ac.jp

Public contact
Name of contact person	1st name Junichi Middle name Last name Tsuchiya
Organization	Medical Hospital Tokyo Medical and Dental University
Division name	Department of Diagnostic Radiology
Zip code	1138519
Address	1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL	03-5803-5311
Homepage URL
Email	tcymrad@tmd.ac.jp

Sponsor
Institute	Department of Diagnostic Radiology,Medical Hospital Tokyo Medical and Dental University
Institute
Department

Funding Source
Organization	Department of Diagnostic Radiology,M edical Hospital Tokyo Medical and Dent al University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Life Sciences and Bioethics, Tokyo Medical and Dental University
Address	1-5-45 Yushima,Bunkyo-ku,Tokyo
Tel	03-5803-4724
Email	info.bec@tmd.ac.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	2020 Year 04 Month 01 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	Preinitiation
Date of protocol fixation	2020 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2020 Year 04 Month 01 Day
Last follow-up date	2025 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	2020 Year 02 Month 25 Day
Last modified on	2020 Year 04 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045020