UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000039594 |
|---|---|
| Receipt number | R000045020 |
| Scientific Title | The study of hypoxia imaging using FAZA(1-(5-[18 F]Fluoro-5-deoxy-alpha-D-arabinofuranosyl)-2-nitroimidazole) |
| Date of disclosure of the study information | 2020/04/01 |
| Last modified on | 2020/04/16 12:09:47 |
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Basic information
Public title
The study of hypoxia imaging using FAZA
Acronym
Hypoxia imaging with FAZA
Scientific Title
The study of hypoxia imaging using FAZA(1-(5-[18 F]Fluoro-5-deoxy-alpha-D-arabinofuranosyl)-2-nitroimidazole)
Scientific Title:Acronym
The study of hypoxia imaging using FAZA
Region
| Japan |
Condition
Condition
ischemic disease, malignant tumor
Classification by specialty
| Medicine in general | Surgery in general | Neurosurgery |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To evaluate clinical usefulness of hypoxia imaging using [F-18] FAZA PET/CT for patients with ischemic disease ore malignant tumors.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
the uptake of [F-18] FAZA in lesions
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
| Medicine |
Interventions/Control_1
FAZA PET/CT
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
Assured for (F-18) FDG PET/CT, greater than or
equal to 20 year of age with written informed
consent
Key exclusion criteria
1.The case who is difficult to participate in the study due to psychological disorders and other diseases.
2.The case who is judged as inappropriate by the physician
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Ukihide |
| Middle name | |
| Last name | Tateishi |
Organization
Medical Hospital Tokyo Medical and De
ntal University
Division name
Department of Diagnostic Radiology
Zip code
1138519
Address
1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL
03-5803-5311
ttisdrnm@tmd.ac.jp
Public contact
Name of contact person
| 1st name | Junichi |
| Middle name | |
| Last name | Tsuchiya |
Organization
Medical Hospital Tokyo Medical and Dental University
Division name
Department of Diagnostic Radiology
Zip code
1138519
Address
1-5-45 Yushima,Bunkyo-ku,Tokyo
TEL
03-5803-5311
Homepage URL
tcymrad@tmd.ac.jp
Sponsor or person
Institute
Department of Diagnostic Radiology,Medical Hospital Tokyo Medical and Dental University
Institute
Department
Personal name
Funding Source
Organization
Department of Diagnostic Radiology,M
edical Hospital Tokyo Medical and Dent
al University
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
Life Sciences and Bioethics, Tokyo Medical and Dental University
Address
1-5-45 Yushima,Bunkyo-ku,Tokyo
Tel
03-5803-4724
info.bec@tmd.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
| 2020 | Year | 04 | 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
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
| 2020 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2020 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2025 | 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
| 2020 | Year | 02 | Month | 25 | Day |
Last modified on
| 2020 | Year | 04 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045020
