Phase 3 N=795 Diagnostic

A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.

Coronary Artery Disease

Bottom Line

View on ClinicalTrials.gov: NCT01347710 ↗

Enrolled (actual)

795

Serious AEs

2.5%

Results posted

Apr 2016

Primary outcome: Primary: Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity — .719; .537 Proportion of true positive cases — p=<0.001

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Flurpiridaz F18 (Drug); 99mTechnicium (sestamibi or tetrofosmin) (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Lantheus Medical Imaging
Primary completion: Jul 2013

Outcome Measures

Outcome	Result	p-value
PRIMARY Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity	.719; .537	<0.001 sig
PRIMARY Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity	.762; .868	.945
SECONDARY Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.	0.736; 0.533; 0.644; 0.356; 0.722; 0.533	<0.001 sig
SECONDARY Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.	.773; .875; .795; .869; .777; .850	0.891
SECONDARY Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).	.495; .333; .398; .251; .596; .476	<0.001 sig
SECONDARY Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).	.867; .932; .904; .970; .845; .912	.379
SECONDARY Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).	.882; .964	0.827
SECONDARY Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).	.882; .964	0.827
SECONDARY Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good	.711; .539	<0.001 sig
SECONDARY Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good	.769; .880	0.954
SECONDARY Image Quality of Rest and Stress (PET vs SPECT).	.891; .739; .976; .869; .109; .261	<0.001 sig
SECONDARY Diagnostic Certainty in PET MPI and SPECT MPI	0.862; 0.138; 0.799; 0.201	<0.001 sig

Summary

The primary objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to single photon emission computed tomography (SPECT) MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a documented history of Myocardial Infarction (MI).

Eligibility Criteria

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 percutaneous coronary intervention within the past six months. See protocol for additional details.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01347710). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.