18F-DTBZ PET and Multi-modal MRI in the Patients With Vascular Parkinsonism
18F-DTBZ PET and Multi-modal MRI in the Patients With Vascular Parkinsonism: Investigating the Correlation Between Cerebral Structural and Functional Changes, and Clinical Manifestation
Studieöversikt
Detaljerad beskrivning
Study duration is expected to be completed in a period of 3 year. The study will enroll 40 patients with VP and 20 healthy subjects.
This neuroimaging study includes the 18F-FP-(+)-DTBZ PET, MRI structure images, diffusion tensor imaging, susceptibility weighted imaging, resting state and gait-related imagery task functional MRI. Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject group, each subject will have 3 visits in this study. Safety measurement for 18F-FP-(+)-DTBZ will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.
Studietyp
Inskrivning (Faktisk)
Fas
- Fas 2
Kontakter och platser
Studieorter
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Taoyuan, Taiwan, 333
- Chang Gung Memory Hospital
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
Inclusion Criteria:
1. Forty patients with a diagnosis of VP whom must: i. Male or female patients; age range 45~80 years old. ii. Written and dated informed consent by self or by legal representative, to be obtained before any of the study procedures.
iii. Patients should be fulfilled the diagnostic criteria of vascular parkinsonism (Appendix I).
2. Twenty healthy subjects whom must: i. Male or female patients; age range 45~80 years old. ii. Written and dated informed consent by self or by legal representative, to be obtained before any of the study procedures.
Exclusion Criteria:
- Pregnant or becoming pregnant during the study (as documented by pregnancy testing at screening or at any date during the study according to the PI discretion) or current breast feeding.
Any subject who has a clinically significant abnormal laboratory values, and/or clinically significant or unstable medical or psychiatric illness.
I. Clinically significant hepatic, renal, pulmonary, metabolic, or endocrine disturbances.
II. Current clinically significant cardiovascular disease. (cardiac surgery or myocardial infarction within the last 6 months; unstable angina; decompensated congestive heart failure; significant cardiac arrhythmia; congenital heart disease.)
- History of drug or alcohol abuse within the last year, or prior prolonged history of abuse.
- History or presence of QTc prolongation.
- History of intracranial operation, including thalamotomy, pallidotomy, and/or deep brain stimulation.
- History of repeated head injury, hydrocephalus, encephalitis or cerebral tumors.
- History of neurotoxin exposure
- Any documented abnormality in the brain by CT or MRI of brain, which might contribute to the motor function, such as hydrocephalus or encephalomalacia, will be excluded. Cerebral vascular lesions are allowed for VP patients. Mild cortical atrophy will be allowed for all subjects.
- Patients who have neurodegenerative diseases, such as spinocerellar atrophy (SCA), Wilson's disease, Parkinson's disease or Parkinson plus syndrome, are excluded.
- General PET exclusion criteria.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Diagnostisk
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 18F-DTBZ for Vascular Parkinsonism
This neuroimaging study includes the 18F-FP-(+)-DTBZ PET, MRI structure images, diffusion tensor imaging, susceptibility weighted imaging, resting state and gait-related imagery task functional MRI.
Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria according the subject group, each subject will have 3 visits in this study.
Safety measurement for 18F-FP-(+)-DTBZ will be evaluated by medical history, vital signs, physical examinations, laboratory examinations and collecting of adverse events.
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During this study, subjects will receive a single i.v. administration of approximately 10 mCi 18F-FP-(+)-DTBZ immediately prior to imaging. The compound is labeled with fluorine 18F that decays by positron (β+) emission and has a half life of 109.7 min. The principal photons useful for diagnostic imaging are the 511 keV gamma photons, resulting from the interaction of the emitted positron with an electron. The proposed dose for this study is based on the phase I study. At the proposed human dose of 10 mCi, the whole body effective dose (ED) will be approximately 680 mrem. The estimated human ED is expected to be comparable to or below the range of other approved brain imaging agents, such as 18F-FDG. |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Tidsram |
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The difference of specific uptake ratio (SUR) of 18F-DTBZ between disease and control group
Tidsram: 3 years
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3 years
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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The correlation between parameters from different imaging modalities and the severity of motor symptoms or cognition in disease group.
Tidsram: 3 years
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The neuroimaging parameters include the SURs of 18F-DTBZ in each brain regions, diffusion indices in each brain regions, MARS score, and activated voxels in each brain regions from the gait-related imagery task functional MRI.
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3 years
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Andra resultatmått
Resultatmått |
Tidsram |
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The difference of diffusion indices obtained from DTI between disease and control group
Tidsram: 3 years
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3 years
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The difference of microbleed anatomical rating scale (MARS) score obtained from the SWI between disease and control group.
Tidsram: 3 years
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3 years
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The difference of functional connectivity maps associated with the seed region of interest (resting state functional MRI) between disease and control group.
Tidsram: 3 years
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3 years
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Samarbetspartners och utredare
Sponsor
Samarbetspartners
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 101-4624A
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