UMIN-CTR Clinical Trial

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
Email	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
Email	kaida@med.kindai.ac.jp

Sponsor
Institute	Department of Radiology, Kindai University Faculty of Medicine
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000027481