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

NCT02195154 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2018-01-31

No results posted yet for this study

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.

Conditions

  • Vascular Parkinsonism

Interventions

DRUG

18F-DTBZ

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.

Sponsors & Collaborators

  • National Science and Technology Council, Taiwan

    collaborator OTHER_GOV

  • Chang Gung Memorial Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2017-07-31
Completion
2017-07-31

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02195154 on ClinicalTrials.gov