UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050769 |
|---|---|
| Receipt number | R000057849 |
| Scientific Title | Exploratory research to evaluate efficacy and predict prognosis of radiation therapy for malignant glioma using tumor uptake of F-BPA. |
| Date of disclosure of the study information | 2023/05/24 |
| Last modified on | 2023/04/05 11:22:34 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Exploratory research to evaluate efficacy and predict prognosis of radiation therapy for malignant glioma using tumor uptake of F-BPA.
Acronym
Exploratory research to evaluate efficacy and predict prognosis of radiation therapy for malignant glioma using tumor uptake of F-BPA.
Scientific Title
Exploratory research to evaluate efficacy and predict prognosis of radiation therapy for malignant glioma using tumor uptake of F-BPA.
Scientific Title:Acronym
Exploratory research to evaluate efficacy and predict prognosis of radiation therapy for malignant glioma using tumor uptake of F-BPA.
Region
| Japan |
Condition
Condition
malignant glioma
Classification by specialty
| Laboratory medicine |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
Focus on the tumor-specific diagnostic potential of F-BPA, we will explore the possibility of using F-BPA PET to evaluate efficacy and predict prognosis of radiation therapy for malignant glioma.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in F-BPA index(SUV= standardized uptake value) before radiotherapy and 3 month after radiotherapy.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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)Patient with malignant glioma undergoing treatment at Osaka Medical and Pharmaceutical University Hospital.
(2)Age at the time of enrollment: 20 years or older.
(3)Consent for participation in the study has been obtained.
Key exclusion criteria
(1)Pregnant women or those who wish to become pregnant.
(2)Under 20years of age.
(3)Difficult to evaluate the lesion.
(4)Patient who are determined to be unable to safely perform this study.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Keiji |
| Middle name | |
| Last name | Nihei |
Organization
Osaka Medical and Pharmaceutical University
Division name
department of radiation oncology
Zip code
569-8686
Address
2-7, Daigaku-machi,Takatsuki,Osaka
TEL
072-683-1221
keiji.nihei@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Keiji |
| Middle name | |
| Last name | Nihei |
Organization
Osaka Medical and Pharmaceutical University
Division name
department of radiation oncology
Zip code
569-8686
Address
2-7, Daigaku-machi,Takatsuki,Osaka
TEL
072-683-1221
Homepage URL
keiji.nihei@ompu.ac.jp
Sponsor or person
Institute
Osaka Medical and Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Kansai BNCT Medical Center, Osaka Medical and Pharmaceutical University
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Osaka
Other related organizations
Co-sponsor
Kansai BNCT Medical Center, Osaka Medical and Pharmaceutical University
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethics committee of Osaka Medical and Pharmaceutical University
Address
2-7, Daigaku-machi, Takatsuki-shi, Osaka
Tel
072-683-1221
rinri@ompu.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
| 2023 | Year | 05 | Month | 24 | 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
| 2023 | Year | 03 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2023 | Year | 05 | Month | 24 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
F-BPA PET imaging will be performed before and 3 months after radiotherapy.
The obtained FBPA PET image data and conventional CT and MRI image data will be evaluated and compared with each other, and F-BPA accumulation in the lesion will be evaluated and compared with the following items to determine efficacy and to predict prognosis.
Management information
Registered date
| 2023 | Year | 04 | Month | 05 | Day |
Last modified on
| 2023 | Year | 04 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057849
