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

A Phase 3, Open Label, Multicenter Study for the Assessment of Myocardial Perfusion Using Positron Emission Tomography (PET) Imaging of Flurpiridaz F18 Injection in Patients With Suspected or Known Coronary Artery Disease (CAD)

Status

Withdrawn

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01681524

Enrollment

Registered

2012-09-10

Start date

2012-11-30

Completion date

2014-05-31

Last updated

2013-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

Keywords

Flurpiridaz F18 Injection, Positron Emission Tomography Myocardial Perfusion Imaging, Single Positron Emission Computed Tomography, Coronary Artery Disease, Myocardia Ischemia, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases

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).

Interventions

DRUGFlurpiridaz F18

Injection of Flurpiridaz F18 for the purposes of PET MPI analysis

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography	12 months

Secondary

Measure	Time frame
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 performance evaluation of CAD (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
Diagnostic certainty evaluation of rest and stress (PETvsSPECT)	12 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026