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

This study has been withdrawn prior to enrollment.
(delayed study start)
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging
ClinicalTrials.gov Identifier:
NCT01681524
First received: August 28, 2012
Last updated: May 29, 2013
Last verified: April 2013

August 28, 2012
May 29, 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 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01681524 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 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 ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
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).

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 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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
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

Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01681524
BMS747158-302
Yes
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