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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001877
Receipt No. R000002261
Scientific Title Evaluation of resistance to radiotherapy by FAZA-PET
Date of disclosure of the study information 2009/04/13
Last modified on 2016/03/18

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Basic information
Public title Evaluation of resistance to radiotherapy by FAZA-PET
Acronym FAZA-PET clinical study 1
Scientific Title Evaluation of resistance to radiotherapy by FAZA-PET
Scientific Title:Acronym FAZA-PET clinical study 1
Region
Japan

Condition
Condition Rectal cancer, Lung cancer
Classification by specialty
Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 To investigate whether PET imaging using a newly developed hypoxia tracer [18F]fluoroazomycin arabinoside (FAZA) can discriminate between radioresistant and radiosensitive cancers in patients planned for radiotherapy.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Tracer uptake in biphasic [18F]FAZA-PET/CT studies
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 Prevention
Type of intervention
Medicine
Interventions/Control_1 FAZA-PET/CT, FDG-PET/CT if necessary
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 Lung cancer patients planned for chemoradiotherapy; Rectal cancer patients planned for chemoradiotherapy
Key exclusion criteria Patients regarded as unsuitable by responsible investigators
Target sample size 80

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tsuneo Saga
Organization National Institute of Radiological Sciences
Division name Molecular Imaging Center
Zip code
Address 4-9-1 Anagawa Inage, Chiba
TEL 043-206-3421
Email saga@nirs.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuneo Saga
Organization National Institute of Radiological Sciences
Division name Molecular Imaging Center
Zip code
Address 4-9-1 Anagawa Inage, Chiba
TEL 043-206-3421
Homepage URL
Email saga@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2009 Year 04 Month 13 Day

Related information
URL releasing protocol
Publication of results Published

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
2008 Year 12 Month 26 Day
Date of IRB
Anticipated trial start date
2009 Year 04 Month 28 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
2009 Year 04 Month 13 Day
Last modified on
2016 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002261

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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