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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: August 14, 2014
Last verified: August 2014
History of Changes
  Purpose

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).


Condition Intervention Phase
Coronary Artery Disease
 Drug: Flurpiridaz F18
 Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: 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)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Lantheus Medical Imaging:

Primary Outcome Measures:
  • Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]
Enrollment: 795
Study Start Date: June 2011
Study Completion Date: September 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 Drug: Flurpiridaz F18
Injection of Flurpiridaz F18 for the purposes of PET MPI analysis

Detailed Description:

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).

  Eligibility
Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01347710

  Show 81 Study Locations
Sponsors and Collaborators
Lantheus Medical Imaging
Investigators
Study Director: Cesare Orlandi, MD Lantheus Medical Imaging
  More Information

No publications provided

Responsible Party: Lantheus Medical Imaging
ClinicalTrials.gov Identifier: NCT01347710     History of Changes
Other Study ID Numbers: BMS747158-301
Study First Received: April 11, 2011
Last Updated: August 14, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Lantheus Medical Imaging:
Coronary Artery Disease.
Positron Emission Tomography Myocardial Perfusion Imaging.
Single Positron Emission Computed Tomography.
Flurpiridaz F18 Injection.

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
 Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on March 03, 2015