UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025923 |
|---|---|
| Receipt number | R000029807 |
| Scientific Title | Drawing a radiation dose distribution curve with improved oxygen effect by a new radiosensitizer (KORTUC) using 18F-Fluoromisoidazole PET molecule imaging. |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2023/02/06 10:50:26 |
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Basic information
Public title
Drawing a radiation dose distribution curve with improved oxygen effect by a new radiosensitizer (KORTUC) using 18F-Fluoromisoidazole PET molecule imaging.
Acronym
Drawing a radiation dose distribution curve with improved oxygen effect by a new radiosensitizer (KORTUC) using 18F-Fluoromisoidazole PET molecule imaging.
Scientific Title
Drawing a radiation dose distribution curve with improved oxygen effect by a new radiosensitizer (KORTUC) using 18F-Fluoromisoidazole PET molecule imaging.
Scientific Title:Acronym
Drawing a radiation dose distribution curve with improved oxygen effect by a new radiosensitizer (KORTUC) using 18F-Fluoromisoidazole PET molecule imaging.
Region
| Japan |
Condition
Condition
carcinoma
Classification by specialty
| Radiology | Adult |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Attempt to visualize the improvement of oxygen effect of a newly developed radiosensitizer (KORTUC) using 18F-Fluoromisonidazole PET/CT.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Attempt to visualize the improvement of oxygen effect of a newly developed radiosensitizer (KORTUC) using 18F-Fluoromisonidazole PET/CT.
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
Treatment
Type of intervention
| Maneuver |
Interventions/Control_1
KORTUC
FMISO 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
Patients with locally advanced cancer to enforce the KORTUC
Key exclusion criteria
Patients under 20 years
Patient difficult to move in the FMISO implementation facility
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Taiju Shimbo |
Organization
Osaka medical college
Division name
Department of radiation oncology
Zip code
Address
2-7,Daigaku-cho,Takatuki,Osaka
TEL
072-683-1221
rad089@osaka-med.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Taiju Shimbo |
Organization
Osaka medical college
Division name
Department of radiation oncology
Zip code
Address
2-7,Daigaku-cho,Takatuki,Osaka
TEL
072-683-1221
Homepage URL
rad089@osaka-med.ac.jp
Sponsor or person
Institute
Osaka medical college
Institute
Department
Personal name
Funding Source
Organization
Osaka medical college
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
Address
Tel
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
| 2017 | Year | 02 | 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
Completed
Date of protocol fixation
| 2017 | Year | 01 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 11 | Month | 10 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | 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
| 2017 | Year | 01 | Month | 31 | Day |
Last modified on
| 2023 | Year | 02 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029807
