Open Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI

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WITHDRAWN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

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2012-11-30

Study Completion Date

2014-05-31

Brief Summary

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The study will evaluate the use of Flurpiridaz F18 injection in patients with CAD to determine if the study drug in PET imaging is better than SPECT imaging currently used for this purpose.

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Detailed Description

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The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz F18 Injection MPI in comparison with SPECT MPI in patients with known or suspected CAD. Six hundred and seventy-two evaluable patients will be enrolled and will undergo SPECT MPI and Flurpiridaz F18 PET MPI. Patients will be considered for enrollment if they are scheduled to undergo or have undergone prior ICA without intervention (being either positive or negative for CAD).

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Flurpiridaz F18

Open-label study of a single injection of flurpiridaz F18 for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary cathertization

Group Type EXPERIMENTAL

Flurpiridaz F18

Intervention Type DRUG

Injection of Flurpiridaz F18 for the purposes of PET MPI analysis

Interventions

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Flurpiridaz F18

Injection of Flurpiridaz F18 for the purposes of PET MPI analysis

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

Invasive Coronary Angiography Men or Women age 18 or older - see protocol for additional details

Exclusion Criteria

Women who are pregnant, lactating, or of child bearing potential who are not practicing birth control Unstable cardiac status History of coronary artery bypass graft History of PCI within the past six months See protocol for additional details

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No