UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Cerebral Blood Flow Measurement of MRI using O-17 labeled water in Normal Subjects and Patients with Chronic Cerebrovascular Disorders
Title of the study (Brief title)	Cerebral Blood Flow Measurement using O-17 labeled water
Region	Japan

Condition
Condition	normal subjects and patients with chronic cerebrovascular disorders
Classification by specialty	Radiology Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	feasibility evaluation of O-17 labeled water
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Signal difference of brain parenchyma between pre- and post-administration of O-17 labeled water and saline
Key secondary outcomes	(1)Efficacy 1)Temporal signal change after administration of O-17 labeled water and saline 2)Correlation between blood flow image and PET in patient group (2)Safety 1) Vital signs (BP, HR, body temperature) 2) Adverse effect

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	Prevention
Type of intervention	Medicine
Interventions/Control_1	intravenous administration of O-17 labeled water
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	65 years-old >
Gender	Male
Key inclusion criteria	Step1(Normal subjects) (1)healthy Japanese male (20 - 65 years old) (2)body weight < 60 kg (3)informed consent is obtained Step2(Patients) (1)Stenosis or occlusion of major craniocervical arteries in MRA, diagnosed within 90 days before obtaining informed consent (2)Diminished regional cerebral blood flow (CBF) in SPECT/PET, diagnosed within 90 days before obtaining informed consent (3)Japanese male (20 - 65 years old) (4)body weight < 60 kg (5)informed consent is obtained
Key exclusion criteria	Step1(Normal subjects) (1)metallic implant or claustrophobia (2)chronic disorders (3)CNS, liver, kidney or heart diease (4)acute infection before 30 days (5)drug allergy (6)chronic intake of drugs (> 30 days) (7)other clinical trial (8)willing to have babies (9)person who is contraindicated for this study due to other reasons Step2(Patients) (1)metallic implant or claustrophobia (2)unstable cardiac function (3)severe hepatic or renal disorders (4)acute infection before 30 days (5)drug allergy (6)screening test (7)willing to have babies (8)other clinical trial (9)person who is contraindicated for this study due to other reasons
Target sample size	23

Research contact person
Name of lead principal investigator	Kohsuke Kudo
Organization	Hokkaido University Hospital
Division name	department of radiology
Address	Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL	011-716-1161
Email	kkudo@huhp.hokudai.ac.jp

Public contact
Name of contact person	Kohsuke Kudo
Organization	Hokkaido University Hospital
Division name	department of radiology
Address	Kita 14 Nishi 5, Kita-ku, Sapporo, Hokkaido
TEL	011-716-1161
Homepage URL
Email	kkudo@huhp.hokudai.ac.jp

Sponsor
Institute	Hokkaido University Hospital
Institute
Department

Funding Source
Organization	Japan Agency for Medical Research and Development (AMED)/Translational Research Network Program
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

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 01 Month 05 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 12 Month 17 Day
Anticipated trial start date	2015 Year 01 Month 05 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 17 Day
Last modified on	2019 Year 03 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018589