UMIN-CTR Clinical Trial

Basic information
Public title	An effectiveness of arterial spin labeling perfusion MRI combined with contrast MRI for determination of tumor typess
Acronym	An effectiveness of arterial spin labeling perfusion MRI combined with contrast MRI for determination of tumor typess
Scientific Title	An effectiveness of arterial spin labeling perfusion MRI combined with contrast MRI for determination of tumor typess
Scientific Title:Acronym	An effectiveness of arterial spin labeling perfusion MRI combined with contrast MRI for determination of tumor typess
Region	Japan

Condition
Condition	Metastatic brain tumor Glioma Lymphoma
Classification by specialty	Radiology Neurosurgery
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the feasibility of non-contrast perfusion MRI(ASL) for differentiating diagnosis of brain tumors in comparison with DSC-MRI by quantitative evaluation in patients with brain tumors
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Non-Inferiority of diagnostic concordance among high grade glioma, Lymphoma and Metastasis by ASL-MRI in comparison with DSC-MRI.
Key secondary outcomes	1. Relationship between category based on discrepancy between ASL imaging and enhanced MR imaging, histological findings of brain tumors. 1. Category : "ASL dominant", and "CE dominant" 2. Diagnostic performance of recurrence and radionecrosis (in primary tumors) by ASL-MRI (Sensitivity, Specificity, PPV, NPV by quantitative evaluation) 3. Relationship between ASL(CBF ) and DSC(CBV, CBF, MTT, Tmax) parameters.

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Diagnosis
Type of intervention	Medicine Device,equipment
Interventions/Control_1	contrast-enhanced MRI
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 who meet all the following criteria can be included in the study: 1.Adult (20 years old or older) 2.Patients with brain tumor suspected (including necrosis, recurrence) 3.Written informed consent is obtained.
Key exclusion criteria	Patients who meet any of the following criteria are not eligible for the study: 1.Contraindication of MRI exam. Patients who have a heart pacemaker, cochlear implant, metallic foreign body, metallic devices 2.Patients who have history of hypersensitivity for Gd contrast media 3.Patients with severe CKD(eGFR<30mL/min/m2) 4.Pregnancy 5.Any others judged ineligible as a subject by the investigator
Target sample size	250

Research contact person
Name of lead principal investigator	1st name Masafumi Middle name Last name Harada
Organization	Tokushima University
Division name	Institute of Biomedical Sciences, School of Medicine
Zip code	770-8509
Address	3-18-15, Kuramoto-cho, Tokushima city, Tokushima 770-8509
TEL	088-633-9283
Email	masafumi@tokushima-u.ac.jp

Public contact
Name of contact person	1st name Takashi Middle name Last name Abe
Organization	Tokushima University
Division name	Institute of Biomedical Sciences, School of Medicine
Zip code	770-8509
Address	3-18-15, Kuramoto-cho, Tokushima city, Tokushima 770-8509
TEL	088-633-9283
Homepage URL
Email	abe.takashi@tokushima-u.ac.jp

Sponsor
Institute	Tokushima university
Institute
Department

Funding Source
Organization	Bayer yakuhin, Ltd
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Tokushima University
Address	3-18-15, Kuramoto-cho, Tokushima city, Tokushima 770-8509
Tel	088-631-3111
Email	abe.takashi@tokushima-u.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	2015 Year 09 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	100
Results
Results date posted
Results Delayed	Delay expected
Results Delay Reason	There is a problem with the analysis and the planned analysis is not completed.
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	No longer recruiting
Date of protocol fixation	2015 Year 05 Month 20 Day
Date of IRB	2015 Year 08 Month 31 Day
Anticipated trial start date	2015 Year 09 Month 01 Day
Last follow-up date	2020 Year 12 Month 31 Day
Date of closure to data entry	2021 Year 03 Month 31 Day
Date trial data considered complete	2021 Year 03 Month 31 Day
Date analysis concluded	2021 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date	2015 Year 07 Month 30 Day
Last modified on	2020 Year 02 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000021401