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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000016516
Receipt No. R000019180
Scientific Title Usefullness of FMISO-PET/CT in head and neck cancer
Date of disclosure of the study information 2015/02/16
Last modified on 2015/02/12

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Basic information
Public title Usefullness of FMISO-PET/CT in head and neck cancer
Acronym Usefullness of FMISO-PET/CT in head and neck cancer
Scientific Title Usefullness of FMISO-PET/CT in head and neck cancer
Scientific Title:Acronym Usefullness of FMISO-PET/CT in head and neck cancer
Region
Japan

Condition
Condition Head and neck cancer
Classification by specialty
Oto-rhino-laryngology Radiology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 Evaluation of the usefullness of FMISO-PET/CT in head and neck cancer.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes comparison of 2hr and 4hr after projection
comparison of FDG and FMISO
reproducibility of this test
change of the hypoxic resion throughout this treatment
prognosis prediction
planning study(dose escalation)
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 clinical use of F-MISO(PET tracer)
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
100 years-old >=
Gender Male and Female
Key inclusion criteria patients of head and neck cancer treated with radiotherapy.
Key exclusion criteria (1)cominication disorder
(2)bad Performance Status
(3)not in concent
(4)women in pregnancy
Target sample size 20

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Hiraoka
Organization Kyoto University Hospital
Division name Department of Radiation Oncology and Image-Applied Therapy
Zip code
Address 606-8507 54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN
TEL 075-751-3762
Email hiraok@kuhp.kyoto-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Michio Yoshimura
Organization Kyoto University Hospital
Division name Department of Radiation Oncology and Image-Applied Therapy
Zip code
Address 606-8507 54 Kawaharacho, Shogoin, Sakyo-ku Kyoto,606-8507, JAPAN
TEL 075-751-3762
Homepage URL
Email myossy@kuhp.kyoto-u.ac.jp

Sponsor
Institute Kyoto University Hospital
Institute
Department

Funding Source
Organization Kyoto University Hospital
Organization
Division
Category of Funding Organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Varian Medical Systems
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 京都大学医学部付属病院

Other administrative information
Date of disclosure of the study information
2015 Year 02 Month 16 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
2015 Year 02 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 01 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
2015 Year 02 Month 12 Day
Last modified on
2015 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019180

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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