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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT01347710
First received: April 11, 2011
Last updated: July 22, 2013
Last verified: February 2013

April 11, 2011
July 22, 2013
June 2011
August 2013   (final data collection date for primary outcome measure)
Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
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 performance evaluation of CAD (PETVsSPECT). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Diagnositic performance evaluation of multivessel disease (PETvsSPECT). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Detection of CAD in subgroups: pharm stress, females and BMI>/=30. [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Image quality of rest and stress (PETvsSPECT). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Diagnostic certainty evaluation of rest and stress (PETvsSPECT). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Evaluation of reversible defect size of rest and stress (PETvsSPECT). [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Safety evaluation of flurpiridaz F 18. [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
  • 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 MPI analysis
Experimental: Flurpiridaz F18
Open-label study of a single dose Flurpiridaz F18 injection for PET MPI compared toSPECT MPI in patients with suspected or known coronary artery disease referred for coronary cathertization
Intervention: Drug: Flurpiridaz F18
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
680
September 2013
August 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 PCI 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
Lantheus Medical Imaging
Lantheus Medical Imaging
Not Provided
Study Director: Cesare Orlandi, MD Lantheus Medical Imaging
Lantheus Medical Imaging
February 2013

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