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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01681524
Recruitment Status : Withdrawn (delayed study start)
First Posted : September 10, 2012
Last Update Posted : May 30, 2013
Information provided by (Responsible Party):
Lantheus Medical Imaging

August 28, 2012
September 10, 2012
May 30, 2013
November 2012
February 2014   (Final data collection date for primary outcome measure)
Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography [ Time Frame: 12 months ]
Same as current
Complete list of historical versions of study NCT01681524 on Archive Site
  • Diagnostic performance evaluation of CAD (PETVsSPECT) [ Time Frame: 12 months ]
  • Diagnositic performance evaluation of multivessel disease (PETvsSPECT) [ Time Frame: 12 months ]
  • Detection of CAD in subgroups: pharm stress, females and BMI>/=30 [ Time Frame: 12 months ]
  • Image quality of rest and stress (PETvsSPECT) [ Time Frame: 12 months ]
  • Diagnostic certainty evaluation of rest and stress (PETvsSPECT) [ Time Frame: 12 months ]
  • Evaluation of reversible defect size of rest and stress (PETvsSPECT) [ Time Frame: 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). [ Time Frame: 12 months ]
Same as current
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Not Provided
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)
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.
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).
Phase 3
Intervention Model: Single Group Assignment
Masking: None (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 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: Drug: Flurpiridaz F18
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
May 2014
February 2014   (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

Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
Not Provided
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Lantheus Medical Imaging
Lantheus Medical Imaging
Not Provided
Study Director: Cesare Orlandi, MD Lantheus Medical Imaging
Lantheus Medical Imaging
April 2013

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