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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT01347710
First received: April 11, 2011
Last updated: March 6, 2016
Last verified: August 2014

April 11, 2011
March 6, 2016
June 2011
July 2013   (final data collection date for primary outcome measure)
  • Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Diagnostic efficacy of one day rest and stress flurpiridaz F 18 PET MPI sensitivity versus SPECT MPI sensitivity in the detection of coronary artery disease (CAD) by majority rule using invasive coronary angiography as the truth standard,
  • Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Diagnostic efficacy of flurpiridaz PET MPI specificity versus SPECT MPI specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard
Assess the diagnostic efficacy (sensitivity and specificity) of flurpiridaz F 18 injection PET MPI compared to SPECT MPI in the detection of significant CAD as defined by ICA or a documented history of MI. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
OUTCOME: 1. Invasive coronary angiography with stenosis ≥ 50%, 2. Documentation of history of MI.
Complete list of historical versions of study NCT01347710 on ClinicalTrials.gov Archive Site
  • Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. [ Time Frame: 60 days ] [ Designated as safety issue: No ]

    Diagnostic efficacy of flurpiridaz F18 PET MPI sensitivity versus SPECT MPI sensitivity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, , in subgroups: pharmacologic stress, females and BMI >/=30. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard

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  • Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30. [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Diagnostic efficacy of flurpiridaz F18 PET MPI specificity versus SPECT specificity by majority rule in the detection of CAD using invasive coronary angiography as the truth standard, in subgroups: pharmacologic stress, females and BMI >/=30. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard
  • Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT). [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Overall sensitivity of flurpiridaz F18 PET MPI in coronary territories (Qualitative Diagnosis vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard
  • Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT). [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Overall specificity of flurpiridaz F18 PET MPI in Coronary Territories (Qualitative Diagnosis) vs. SPECT MPI by majority rule vs. truth standard (angiographic stenosis greater than or equal to 50% stenosis and confirmed MI); left descending coronary artery (LAD), left circumflex artery (LCX), right coronary artery (RCA), and non - LAD. Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard
  • Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT). [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Overall summary of sensitivity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. truth standard (angio >/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard
  • Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT). [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Overall summary of specificity for identifying multi-vessel disease between flurpiridaz F18 PET MPI and SPECT MPI by majority rule vs. majority rule (angio >/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard
  • Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Overall summary of sensitivity of flurpiridaz F18 PET MPI (qualitative image quality of excellent or good) vs. SPECT MPI by majority rule vs. truth standard(angio >/=50% stenosis and confirmed MI). Value reported is the number of true positives, i.e. True Positive: Patients with abnormal MPI and disease positive by the truth standard
  • Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Overall summary of specificity of flurpiridaz F18 PET MPI (qualitative, image quality excellent or good) vs. SPECT MPI by majority rule vs truth standard (angio >/=50% stenosis and confirmed MI). Value represents the number of true negative, i.e. True Negative: Patients with normal MPI and disease negative by the truth standard
  • Image Quality of Rest and Stress (PET vs SPECT). [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Overall summary of rest and stress image quality for flurpiridaz F18 PET MPI and SPECT MPI by majority rule. Value represents the number of subject images evaluated as excellent/good and fair/poor
  • Diagnostic Certainty in PET MPI and SPECT MPI [ Time Frame: 60 days ] [ Designated as safety issue: No ]
    Overall summary of diagnostic certainty in flurpiridaz F18 PET MPI and SPECT MPI by majority rule
  • Evaluate the diagnostic performance characteristics of flurpiridaz F 18 injection PET MPI compared to SPECT MPI for identifying the location of significant CAD. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    OUTCOME: The ICA identification of disease in individual vascular areas compared to PET and SPECT MPI with flurpiridaz F 18.
  • Evaluate the diagnostic performance characteristics of flurpiridaz F 18 injection PET MPI compared to SPECT MPI for identifying multivessel CAD. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    OUTCOME: Flurpiridaz F 18 concentration in smaller vessels identified on images in multiple vessels.
  • Assess diagnostic efficacy of flurpiridaz F 18 injection PET MPI compared to SPECT MPI in detection of significant CAD in specific population subgroups: Patients undergoing pharmacologic stress; Female patients; Patients with a body mass index BMI ≥ 30. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    OUTCOME: Comparative diagnostic performance of PET and SPECT with flurpiridaz F 18.
  • Evaluate the image quality of rest and stress flurpiridaz F 18 injection PET MPI as compared to SPECT MPI. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    OUTCOME: Assessment of the ability of flurpiridaz F 18 to provide higher quality images in PET over SPECT with a more definitive diagnosis of disease.
  • Evaluate the diagnostic certainty of rest and stress flurpiridaz F 18 injection PET MPI as compared to SPECT MPI. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    OUTCOME: Investigation of the higher proportion of excellent or good images from PET versus SPECT using flurpiridaz F 18.
  • Evaluate the reversible defect size (extent and severity) of rest and stress flurpiridaz F 18 injection PET MPI compared to SPECT MPI. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    OUTCOME: Assessment of the improved flow characteristics and image quality of flupiridaz F 18 that may result in differences in reversible defect size. The defect size comparison will be performed using a semi-quantitative SDS score that characterizes reversible ischemia.
  • Safety evaluation of flurpiridaz F 18. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    OUTCOME: The overall incidence of AEs (ie, AEs occurring from the time the informed consent is signed until the 2-week telephone follow-up [14-17 days post-flurpiridaz F 18 injection administration]) and treatment-emergent adverse events (TEAEs) (ie, AEs occurring at the time of flurpiridaz F 18 rest dose administration until the 14-17 day telephone follow-up) and the proportion of patients who discontinue because of an AE or TEAE are the primary safety outcome measures.
Not Provided
Not Provided
 
A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD.
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)
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).
The study will assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz F18 Injection MPI against SPECT MPI in patients screened for CAD as determined by ICA. Six hundred and eighty 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).
Interventional
Phase 3
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Coronary Artery Disease
  • Drug: Flurpiridaz F18
    Injection of Flurpiridaz F18 for the purposes of PET myocardial profusion imaging (MPI) analysis
    Other Name: flurpiridaz F 18
  • Drug: 99mTechnicium (sestamibi or tetrofosmin)
    Injection of 99mTc sestamibi or tetrofosmin for the purposes of SPECT MPI analysis
    Other Name: 99mTc sestamibi or 99mTc Tetrofosmin
Experimental: Flurpiridaz F18
Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to a single dose of 99mTc sestamibi or tetrofosmin for SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization
Interventions:
  • Drug: Flurpiridaz F18
  • Drug: 99mTechnicium (sestamibi or tetrofosmin)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
795
September 2013
July 2013   (final data collection date for primary outcome measure)

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.

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada,   Finland,   Puerto Rico
 
NCT01347710
BMS747158-301
Yes
Not Provided
Not Provided
Lantheus Medical Imaging
Lantheus Medical Imaging
Not Provided
Study Director: Cesare Orlandi, MD Lantheus Medical Imaging
Lantheus Medical Imaging
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP