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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This study has been withdrawn prior to enrollment.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
History of Changes
  Purpose

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.


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 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 ]

Enrollment: 0
Study Start Date: November 2012
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: February 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
 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 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).

  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681524

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: NCT01681524     History of Changes
Other Study ID Numbers: BMS747158-302
Study First Received: August 28, 2012
Last Updated: May 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Lantheus Medical Imaging:
Flurpiridaz F18 Injection
Positron Emission Tomography Myocardial Perfusion Imaging
Single Positron Emission Computed Tomography
Coronary Artery Disease
Myocardia Ischemia
Coronary Disease
 Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

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

ClinicalTrials.gov processed this record on June 17, 2013