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
Results First Received: January 24, 2016  
Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Diagnostic
Condition: Coronary Artery Disease
Interventions: Drug: Flurpiridaz F18
Drug: 99mTechnicium (sestamibi or tetrofosmin)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Flurpiridaz F 18 Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization

Participant Flow:   Overall Study
    Flurpiridaz F 18  
STARTED     795  
COMPLETED     764  
NOT COMPLETED     31  
Withdrawal by Subject                 2  
Adverse Event                 4  
Angio or SPECT not completed                 18  
issue with vitals prior to dosing                 1  
Lost to Follow-up                 1  
Physician Decision                 2  
Unknown                 3  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population, received at least one dose of flurpiridaz F 18

Reporting Groups
  Description
Flurpiridaz F 18 Open-label study of a single dose of Flurpiridaz F18 injection for PET MPI compared to SPECT MPI in patients with suspected or known coronary artery disease referred for coronary catheterization

Baseline Measures
    Flurpiridaz F 18  
Number of Participants  
[units: participants]
  795  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     458  
>=65 years     337  
Gender  
[units: participants]
 
Female     249  
Male     546  
Ethnicity (NIH/OMB)  
[units: participants]
 
Hispanic or Latino     43  
Not Hispanic or Latino     708  
Unknown or Not Reported     44  
Race (NIH/OMB)  
[units: participants]
 
American Indian or Alaska Native     2  
Asian     8  
Native Hawaiian or Other Pacific Islander     4  
Black or African American     105  
White     652  
More than one race     0  
Unknown or Not Reported     24  



  Outcome Measures
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1.  Primary:   Diagnostic Efficacy of Flurpiridaz F 18 PET Myocardial Perfusion Imaging (MPI) Sensitivity Versus SPECT Myocardial Perfusion Imaging Sensitivity   [ Time Frame: 60 days ]

2.  Primary:   Diagnostic Efficacy of Flurpiridaz PET MPI Specificity Versus SPECT MPI Specificity   [ Time Frame: 60 days ]

3.  Secondary:   Diagnostic Efficacy of Flurpiridaz F18 PET MPI Sensitivity Versus SPECT MPI Sensitivity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.   [ Time Frame: 60 days ]

4.  Secondary:   Diagnostic Efficacy of Flurpiridaz F18 PET MPI Specificity Versus SPECT Specificity in Subgroups: Pharmacologic Stress, Females and BMI>/=30.   [ Time Frame: 60 days ]

5.  Secondary:   Diagnostic Performance Evaluation of Localization of CAD for Sensitivity (PETVsSPECT).   [ Time Frame: 60 days ]

6.  Secondary:   Diagnostic Performance Evaluation of Localization of CAD for Specificity (PETVsSPECT).   [ Time Frame: 60 days ]

7.  Secondary:   Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).   [ Time Frame: 60 days ]

8.  Secondary:   Diagnositic Performance Evaluation of Multivessel Disease (PETvsSPECT).   [ Time Frame: 60 days ]

9.  Secondary:   Overall Summary of Sensitivity of PET MPI vs SPECT MPI; Image Quality Excellent or Good   [ Time Frame: 60 days ]

10.  Secondary:   Overall Summary of Specificity of PET MPI vs SPECT MPI; Image Quality of Excellent or Good   [ Time Frame: 60 days ]

11.  Secondary:   Image Quality of Rest and Stress (PET vs SPECT).   [ Time Frame: 60 days ]

12.  Secondary:   Diagnostic Certainty in PET MPI and SPECT MPI   [ Time Frame: 60 days ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: CMO
Organization: Lantheus Medical Imaging
phone: 978-671-8544
e-mail: c.orlandi@lantheus.com



Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT01347710     History of Changes
Other Study ID Numbers: BMS747158-301
Study First Received: April 11, 2011
Results First Received: January 24, 2016
Last Updated: March 6, 2016
Health Authority: United States: Food and Drug Administration