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

Phase 3

Withdrawn

• Conditions: Coronary Artery Disease
• Interventions: Drug: Flurpiridaz F18

• Registration Number: NCT01681524
• Lead Sponsor: Lantheus Medical Imaging

Brief Summary

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.

Detailed Description

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).

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2012-08-28
• Study First Submitted QC: 2012-09-05
• Study First Posted: 2012-09-10
• Study Start: 2012-11
• Status Verified: 2013-04
• Last Update Submitted: 2013-05-29
• Last Update Posted: 2013-05-30
• Primary Completion: 2014-02
• Study Completion: 2014-05

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Flurpiridaz F18	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

Primary Outcome Measures

Name	Time	Method
Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography	12 months

Secondary Outcome Measures

Name	Time	Method
Diagnostic performance evaluation of CAD (PETVsSPECT)	12 months
Diagnositic performance evaluation of multivessel disease (PETvsSPECT)	12 months
Detection of CAD in subgroups: pharm stress, females and BMI>/=30	12 months
Image quality of rest and stress (PETvsSPECT)	12 months
Diagnostic certainty evaluation of rest and stress (PETvsSPECT)	12 months
Evaluation of reversible defect size of rest and stress (PETvsSPECT)	12 months
Safety evaluation of flurpiridaz F 18 will include monitoring the number participants with adverse events (AEs), medication errors, treatment-emergent adverse events (TEAEs), and serious adverse events (SAEs).	12 months