normal subjects and patients with chronic cerebrovascular disorders
Conditions
Interventions
intravenous administration of O-17 labeled water
Sponsors
Hokkaido University Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Signal difference of brain parenchyma between pre- and post-administration of O-17 labeled water and saline | — |
Secondary
| Measure | Time frame |
|---|---|
| (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 | — |
Countries
Japan
Contacts
Public ContactKohsuke Kudo
Hokkaido University Hospital department of radiology
Outcome results
None listed