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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.
 
ClinicalTrials.gov Identifier: NCT01681524
Recruitment Status : Withdrawn (delayed study start)
First Posted : September 10, 2012
Last Update Posted : May 30, 2013
Sponsor:
Information provided by (Responsible Party):
Lantheus Medical Imaging

Tracking Information
First Submitted Date  ICMJE August 28, 2012
First Posted Date  ICMJE September 10, 2012
Last Update Posted Date May 30, 2013
Study Start Date  ICMJE November 2012
Estimated Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography [ Time Frame: 12 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 5, 2012)
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Open Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI
Official Title  ICMJE 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)
Brief Summary 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.
Detailed Description 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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Coronary Artery Disease
Intervention  ICMJE Drug: Flurpiridaz F18
Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
Study Arms  ICMJE 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: April 2, 2013)
0
Original Estimated Enrollment  ICMJE
 (submitted: September 5, 2012)
672
Estimated Study Completion Date  ICMJE May 2014
Estimated Primary Completion Date February 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01681524
Other Study ID Numbers  ICMJE BMS747158-302
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lantheus Medical Imaging
Study Sponsor  ICMJE Lantheus Medical Imaging
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Cesare Orlandi, MD Lantheus Medical Imaging
PRS Account Lantheus Medical Imaging
Verification Date April 2013

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