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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000034193
Receipt No. R000038982
Scientific Title Evaluation of blood flow of malignant tumor using O-15 water PET: the effect of blood flow on therapeutic response
Date of disclosure of the study information 2018/10/01
Last modified on 2019/06/12

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Basic information
Public title Evaluation of blood flow of malignant tumor using O-15 water PET: the effect of blood flow on therapeutic response
Acronym Evaluation of blood flow of malignant tumor using O-15 water PET
Scientific Title Evaluation of blood flow of malignant tumor using O-15 water PET: the effect of blood flow on therapeutic response
Scientific Title:Acronym Evaluation of blood flow of malignant tumor using O-15 water PET
Region
Japan

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

Objectives
Narrative objectives1 Tumor blood flow is measured using 15 O-water PET for patients with lung cancer before chemotherapy and whether tumor blood flow is a predictive factor of chemotherapy effect will be verified.
Basic objectives2 Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Tumor blood flow in patients with lung cancer
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
Other
Interventions/Control_1 O-15 water PET
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 1) In our respiratory department internal medicine patient who had lung cancer before chemotherapy with anticancer drug for the first time. However, patients with adjuvant chemotherapy and chemoradiotherapy are excluded. Treatment history of molecular targeted drugs other than chemotherapy with cell-mediated anticancer drugs, surgery, radiotherapy and the like is not limited.
2) Adult patients over the age of 20
3) Patients who have written written consent about their participation in this study at their own will
Key exclusion criteria 1) Patients who are assumed to be difficult to implement this PET examination due to general condition etc.
2) Women who are pregnant
3) Other patients who are judged inappropriate by research researcher, etc.
Target sample size 24

Research contact person
Name of lead principal investigator
1st name Hiroki
Middle name
Last name Kato
Organization Osaka University Graduate School of Medicine
Division name Nuclear Medicine and Tracer Kinetics
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka, 565-0871, JAPAN
TEL 06-6879-3461
Email kato@tracer.med.osaka-u.ac.jp

Public contact
Name of contact person
1st name Tadashi
Middle name
Last name Watabe
Organization Osaka University Graduate School of Medicine
Division name Nuclear Medicine and Tracer Kinetics
Zip code 565-0871
Address 2-2 Yamadaoka, Suita, Osaka, 565-0871, JAPAN
TEL 06-6879-3461
Homepage URL
Email watabe@tracer.med.osaka-u.ac.jp

Sponsor
Institute Osaka University Graduate School of Medicine
Institute
Department

Funding Source
Organization Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization Japanese Governmental office
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization Osaka University School of Medicine Hospital Ethics Committee
Address 2-2 Yamadaoka, Suita, Osaka, 565-0871, JAPAN
Tel 06-6210-8296
Email rinri@hp-crc.med.osaka-u.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
2018 Year 10 Month 01 Day

Related information
URL releasing protocol
Publication of results Partially 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 Open public recruiting
Date of protocol fixation
2018 Year 09 Month 01 Day
Date of IRB
2019 Year 04 Month 12 Day
Anticipated trial start date
2019 Year 05 Month 08 Day
Last follow-up date
2020 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
2018 Year 09 Month 18 Day
Last modified on
2019 Year 06 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038982

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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