Clinical trial NCT01681524: Open Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI
Official title: 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)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
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
Lead sponsor: Lantheus Medical Imaging
Sponsor class: INDUSTRY
First posted: 2012-09-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

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 PCI within the past six months See protocol for additional details

Primary outcomes:
measure: Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography
timeFrame: 12 months
Secondary outcomes:
measure: Diagnostic performance evaluation of CAD (PETVsSPECT)
timeFrame: 12 months
measure: Diagnositic performance evaluation of multivessel disease (PETvsSPECT)
timeFrame: 12 months
measure: Detection of CAD in subgroups: pharm stress, females and BMI>/=30
timeFrame: 12 months
measure: Image quality of rest and stress (PETvsSPECT)
timeFrame: 12 months
measure: Diagnostic certainty evaluation of rest and stress (PETvsSPECT)
timeFrame: 12 months
measure: Evaluation of reversible defect size of rest and stress (PETvsSPECT)
timeFrame: 12 months
measure: 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).
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Lantheus Medical Imaging
name: Cesare Orlandi, MD
role: STUDY_DIRECTOR
References: