UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Assessment of Blood Flow, Vascular Permeability and Oxygen Metabolism in Brain Tumors with Magnetic Resonance Imaging
Title of the study (Brief title)	Assessment of Oxygen Metabolism in Brain Tumors with MRI
Region	Japan

Condition
Condition	Normal subjects and patients with brain tumors
Classification by specialty	Radiology
Classification by malignancy	Malignancy
Genomic information	NO

Objectives
Narrative objectives1	(1) Establishment of QSM (2) Feasibility evaluation of QSM, ASL and DCE in assessment of brain tumors
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Step 1-2 Correlation between StO2 values of lower extremity calculated by QSM and percutaneously measured by pulse oxymeter. Step 2 (1)Correlation between StO2 value calculated by QSM and 18F-FMISO accumulation (2)Comparison between distributions of hypoxic areas illustrated by QSM and FMISO-PET
Key secondary outcomes	Step 1-2 Correration between StO2 value of lower extremity calculated by QSM and applied pressure Step 2 (1)Correlations between MRI findings in ASL/DCE and 18F-FMISO accumulation (2)Relation between results in radiation therapy and MR findings before radiation, change in MR findings between pre and post radiation (3)Relation between histopathology and MR findings in metastatic brain tumors

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	Diagnosis
Type of intervention	Other
Interventions/Control_1	Additional performance of QSM, ASL and DCE to conventional 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	60 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Healthy volunteers 1.Healthy male and female (20 - 60 years old) 2.Informed consent is obtained (2)Patients with brain tumors 1.Adult 2.Brain tumors with diameter of no less than 1cm shown in enhanced MRI 3.FMISO-PET performed at our institute 4.Preserved major organ functions 5.Metastatic brain tumors histopathologically diagnosed by extracranial lesions 6.Informed consent is obtained
Key exclusion criteria	1.Metallic implant or device not applicable to MRI 2.Unable to be at rest on his/her back or claustrophobia 3.Pregnant 4.Other inadequate cases 5.Allergic to gadlinium agents 6.Renal failure
Target sample size	60

Research contact person
Name of lead principal investigator	Kohsuke Kudo
Organization	Hokkaido University Hospital
Division name	Department of Diagnostic and Interventional Radiology
Address	north 14, west 5, Kita-ku, Sapporo
TEL	011-706-5977
Email	kkudo@huhp.hokudai.ac.jp

Public contact
Name of contact person	Yukie Shimizu
Organization	Hokkaido University Hospital
Division name	Department of Diagnostic and Interventional Radiology
Address	north 14, west 5, Kita-ku, Sapporo
TEL	011-706-5977
Homepage URL
Email	yshimizu1222@yahoo.co.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Hitach, Ltd. Hitach Medical Corporation
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor	Hitach, Ltd. Hitach Medical Corporation
Name of secondary funｄer(s)	Bayer Yakuhin, Ltd.

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	2014 Year 12 Month 03 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 10 Month 15 Day
Anticipated trial start date	2014 Year 12 Month 08 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 12 Month 02 Day
Last modified on	2019 Year 02 Month 13 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018407