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18F-DTBZ PET and Multi-modal MRI in the Patients With Vascular Parkinsonism

Primary Purpose

Vascular Parkinsonism

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

18F-DTBZ

About this trial

This is an interventional diagnostic trial for Vascular Parkinsonism focused on measuring 18F-DTBZ

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Chang Gung Memory Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

18F-DTBZ for Vascular Parkinsonism

Arm Description

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.

Outcomes

Primary Outcome Measures

The difference of specific uptake ratio (SUR) of 18F-DTBZ between disease and control group

Secondary Outcome Measures

The correlation between parameters from different imaging modalities and the severity of motor symptoms or cognition in disease group.

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.

Full Information

NCT ID

NCT02195154

First Posted

February 27, 2014

Last Updated

January 29, 2018

Sponsor

Chang Gung Memorial Hospital

Collaborators

National Science Council, Taiwan

1. Study Identification

Unique Protocol Identification Number

NCT02195154

Brief Title

18F-DTBZ PET and Multi-modal MRI in the Patients With Vascular Parkinsonism

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

November 2013 (Actual)

Primary Completion Date

July 31, 2017 (Actual)

Study Completion Date

July 31, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Chang Gung Memorial Hospital

Collaborators

National Science Council, Taiwan

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Forty patients with clinically diagnosed VP and 20 healthy subjects will be enrolled in the study. Each evaluable subject involved in this study must fulfill all the inclusion and exclusion criteria and each subject will have 3 visits in the study, as one screening visit, one imaging visit, and one safety evaluation visit.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Vascular Parkinsonism

Keywords

18F-DTBZ

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

13 (Actual)

8. Arms, Groups, and Interventions

Arm Title

18F-DTBZ for Vascular Parkinsonism

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

18F-DTBZ

Intervention Description

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.

Primary Outcome Measure Information:

Title

The difference of specific uptake ratio (SUR) of 18F-DTBZ between disease and control group

Time Frame

3 years

Secondary Outcome Measure Information:

Title

The correlation between parameters from different imaging modalities and the severity of motor symptoms or cognition in disease group.

Description

Time Frame

3 years

Other Pre-specified Outcome Measures:

Title

The difference of diffusion indices obtained from DTI between disease and control group

Time Frame

3 years

Title

The difference of microbleed anatomical rating scale (MARS) score obtained from the SWI between disease and control group.

Time Frame

3 years

Title

The difference of functional connectivity maps associated with the seed region of interest (resting state functional MRI) between disease and control group.

Time Frame

3 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

Chang Gung Memory Hospital

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

12. IPD Sharing Statement

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18F-DTBZ PET and Multi-modal MRI in the Patients With Vascular Parkinsonism

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