UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034193 |
|---|---|
| Receipt number | 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 | 2023/03/23 10:28:53 |
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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
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
watabe@tracer.med.osaka-u.ac.jp
Sponsor or person
Institute
Osaka University Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Japan
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
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 | 09 | Month | 30 | 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
| 2023 | Year | 03 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038982
