UMIN-CTR Clinical Trial

Basic information
Public title	The study to compare the hypoxic imaging of 18F-FAZA-PET/CT with the glucose metabolic imaging of 18F-FDG-PET/CT in patients with tumor
Acronym	The comparison study between 18F-FAZA-PET/CT and 18F-FDG-PET/CT
Scientific Title	The study to compare the hypoxic imaging of 18F-FAZA-PET/CT with the glucose metabolic imaging of 18F-FDG-PET/CT in patients with tumor
Scientific Title:Acronym	The comparison study between 18F-FAZA-PET/CT and 18F-FDG-PET/CT
Region	Japan

Condition
Condition	Malignant tumors
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	The aim of this study is to examine the diagnostic, therapeutic and prognostic values of 18F-FAZA-PET/CT for patients with malignant tumor by comparing with 18F-FDG-PET/CT.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	We compare the18F-FAZA-PET/CT findings with 18F-FDG-PET/CT findings before and after therapy in patients with malignant tumor.
Key secondary outcomes	Assessment of changes of the visual findings of both PET/CT examinations before and after therapy Assessment of changes of the quantitative parameters (SUV, MTV and TLG) of both PET/CT examinations before and after therapy

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Cluster
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	The 18F-FAZA-PET/CT examination is performed in patient with malignant tumor before and after therapy
Interventions/Control_2	The 18F-FDG-PET/CT examination is performed in patient with malignant tumor before and after therapy
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	Patients with malignant tumor who will be performed treatment
Key exclusion criteria	Patients with malignant tumor who will not be performed treatment
Target sample size	160

Research contact person
Name of lead principal investigator	1st name Masatoyo Middle name Last name Nakajo
Organization	Nanpuh Hospital
Division name	Radiology
Zip code	892-8512
Address	14-3 Nagata, Kagoshima, Japan
TEL	099-226-9111
Email	toyo.nakajo@dolphin.ocn.ne.jp

Public contact
Name of contact person	1st name Yoriko Middle name Last name Kajiya
Organization	Nanpuh Hospital
Division name	Radiology
Zip code	892-8512
Address	14-3 Nagata, Kagoshima, Japan
TEL	099-226-9111
Homepage URL
Email	toyo.nakajo@dolphin.ocn.ne.jp

Sponsor
Institute	Nanpuh Hospital
Institute
Department

Funding Source
Organization	Nanpuh Hospital
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	Nanpuh Hospital
Address	14-3 Nagata, Kagoshima, Japan
Tel	099-226-9111
Email	crc-kenkyu@nanpuh.or.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	南風病院(鹿児島県)

Other administrative information
Date of disclosure of the study information	2016 Year 07 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	22
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	2016 Year 05 Month 01 Day
Date of IRB	2016 Year 05 Month 26 Day
Anticipated trial start date	2016 Year 07 Month 01 Day
Last follow-up date	2019 Year 03 Month 25 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 06 Month 20 Day
Last modified on	2019 Year 07 Month 11 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026276