UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023933 |
|---|---|
| Receipt number | R000027481 |
| Scientific Title | To elucidate the prognostic marker using amino acid PET imaging and signal transduction factors in brain tumor patients |
| Date of disclosure of the study information | 2016/11/01 |
| Last modified on | 2021/03/13 00:24:49 |
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Basic information
Public title
To elucidate the prognostic marker using amino acid PET imaging and signal transduction factors in brain tumor patients
Acronym
To elucidate the prognostic marker using amino acid PET imaging and signal transduction factors in brain tumor patients
Scientific Title
To elucidate the prognostic marker using amino acid PET imaging and signal transduction factors in brain tumor patients
Scientific Title:Acronym
To elucidate the prognostic marker using amino acid PET imaging and signal transduction factors in brain tumor patients
Region
| Japan |
Condition
Condition
brain tumor (glioma)
Classification by specialty
| Radiology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
To reveal the correlation between 11C-methionine (MET) PET uptake and signal transduction factors in patients with glioma.
We investigate the relationships between survival rate and MET uptake parameters, signal transduction factors, and clinicopathological factors. We elucidate the optimal prognostic markers of glioma among these relationships.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the optimal MET uptake parameter and signal transduction factor for prognosis of glioma patients.
Key secondary outcomes
To reveal whether we predict the expression of signal transduction factors and the degree of malignancy using MET uptake parameters.
To investigate whether MET uptake and the expression of signal transduction factors have an influence on the management of therapy such as molecular target therapy in glioma patients.
To reveal the relationship between amino acid metabolism and tumorgenesis of glioma using MET uptake, signal transduction factors, and clnicopathological factors.
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
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
(1)The patient undergoes MET PET/CT in Kindai University Hospital.
(2)The patient is diagnosed as glioma with CT, MRI and other clinical findings at neurosurgery in Kindai University Hospital, and is needed to surgery or biospsy.
(3)The age of the patient is over 20 age years.
(4)The document about the agreement with participation of this study is obtained from patient.
Key exclusion criteria
(1)The patient has metastatic brain tumor, malignant lymphoma or other brain tumors and malignant tumors.
(2)The glioma patient without treatment adaptation.
(3)The document about the agreement with participation of this study is not obtained from patient.
(4)Pregnant woman, possibility of the pregnancy woman, lactating woman.
(5)The age of the patient is less than 20 age years.
(6)The patient cannot undergo PET/CT examination because of serious complication
(7)The doctor makes a judgement that the patient is not appropriate for participatingin this study.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hayato |
| Middle name | |
| Last name | Kaida |
Organization
Kindai University Faculty of Medicine
Division name
Department of Radiology
Zip code
5898511
Address
Ohnohigashi 377-2, Osakasayama City, Osaka, 589-8511, Japan
TEL
072-366-0221
kaida@med.kindai.ac.jp
Public contact
Name of contact person
| 1st name | Hayato |
| Middle name | |
| Last name | Kaida |
Organization
Kindai University Faculty of Medicine
Division name
Department of Radiology
Zip code
5898511
Address
Ohnohigashi 377-2, Osakasayama City, Osaka, 589-8511, Japan
TEL
072-366-0221
Homepage URL
kaida@med.kindai.ac.jp
Sponsor or person
Institute
Department of Radiology, Kindai University Faculty of Medicine
Institute
Department
Personal name
Funding Source
Organization
Japan Society For the Promotion of Science
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Kurume University School of Medicine.
Kurume University Hospital
Graduate School of Medicine/ Faculty of Medicine, Osaka University
Name of secondary funder(s)
Kobe University Graduate School of Medicine
IRB Contact (For public release)
Organization
Ethics Committee Kindai University Faculty of Medicine
Address
Ohnohigashi 377-2, Osakasayama City, Osaka, 589-8511, Japan
Tel
072-366-0221
zizen@med.kindai.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
| 2016 | Year | 11 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 11 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The purpose of this study is to show the correlation between MET uptake and signal trasduction factors, and reveal the optimal prognostic factors from the relationship between survival rate and MET uptake, signal trasduction factors and clinicopathological factors in glioma patients. In addition, we investigate pathological relationship between amino acid metabolism and tumor progression of glioma.
Management information
Registered date
| 2016 | Year | 09 | Month | 05 | Day |
Last modified on
| 2021 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027481
