Evaluation of Electronic Florbetapir (18F) Interpretation Training in Japanese Physicians

NCT ID: NCT02029547

Last Updated: 2014-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-05-31

Brief Summary

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This study is designed to validate the Japanese electronic florbetapir (18F) interpretation training program intended for post-approval implementation in Japan.

Detailed Description

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Conditions

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Alzheimer's Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Physician Readers

Physician readers will interpret 60 Amyvid scans using qualitative analysis followed by the use of quantitation. No subjects will be exposed to florbetapir (18F) as part of this study.

Group Type EXPERIMENTAL

Florbetapir (18F)

Intervention Type DRUG

No Florbetapir (18F) will be administered in this study.

Interventions

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Florbetapir (18F)

No Florbetapir (18F) will be administered in this study.

Intervention Type DRUG

Other Intervention Names

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Florbetapir F 18 florbetapir Amyvid 18F-AV-45

Eligibility Criteria

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Inclusion Criteria

* Japanese Society of Nuclear Medicine (JSNM) Positron Emission Tomography (PET) Certified Nuclear Medicine Physician
* Minimal hands-on experience and no formal training in the visual interpretation of florbetapir (18F) brain PET scans
* Minimal hands-on experience and no formal training in the quantitation of florbetapir (18F) brain PET scans

Exclusion Criteria

* Prior hands-on experience or formal training in the visual interpretation and/or quantitation of florbetapir (18F) PET scans
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Avid Radiopharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Tokyo, , Japan

Site Status

Countries

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Japan

Other Identifiers

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18F-AV-45-JPT01

Identifier Type: -

Identifier Source: org_study_id

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