Back to resultsOpen Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI
Primary Purpose
Coronary Artery Disease
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Flurpiridaz F18
Sponsored by
About this trial
This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring 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
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Flurpiridaz F18
Arm Description
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
Outcomes
Primary Outcome Measures
Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography
Secondary Outcome Measures
Diagnostic performance evaluation of CAD (PETVsSPECT)
Diagnositic performance evaluation of multivessel disease (PETvsSPECT)
Detection of CAD in subgroups: pharm stress, females and BMI>/=30
Image quality of rest and stress (PETvsSPECT)
Diagnostic certainty evaluation of rest and stress (PETvsSPECT)
Evaluation of reversible defect size of rest and stress (PETvsSPECT)
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01681524
Brief Title
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
2. Study Status
Record Verification Date
April 2013
Overall Recruitment Status
Withdrawn
Why Stopped
delayed study start
Study Start Date
November 2012 (undefined)
Primary Completion Date
February 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lantheus Medical Imaging
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Flurpiridaz F18
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Flurpiridaz F18
Intervention Description
Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
Primary Outcome Measure Information:
Title
Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Diagnostic performance evaluation of CAD (PETVsSPECT)
Time Frame
12 months
Title
Diagnositic performance evaluation of multivessel disease (PETvsSPECT)
Time Frame
12 months
Title
Detection of CAD in subgroups: pharm stress, females and BMI>/=30
Time Frame
12 months
Title
Image quality of rest and stress (PETvsSPECT)
Time Frame
12 months
Title
Diagnostic certainty evaluation of rest and stress (PETvsSPECT)
Time Frame
12 months
Title
Evaluation of reversible defect size of rest and stress (PETvsSPECT)
Time Frame
12 months
Title
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).
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cesare Orlandi, MD
Organizational Affiliation
Lantheus Medical Imaging
Official's Role
Study Director
12. IPD Sharing Statement
Learn more about this trial
Open Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI
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