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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000022799
Receipt No. R000026276
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
Date of disclosure of the study information 2016/07/01
Last modified on 2019/07/11

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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/ctr_e/ctr_view.cgi?recptno=R000026276

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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