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

Coronary Artery Disease Clinical Trial

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)

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01681524
• Other study ID #: BMS747158-302
• Status: Withdrawn
• Phase: Phase 3
• First received: August 28, 2012
• Last updated: May 29, 2013
• Start date: November 2012
• Est. completion date: May 2014

Study information

• Verified date: April 2013
• Source: Lantheus Medical Imaging
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Drug:
• Flurpiridaz F18
Injection of Flurpiridaz F18 for the purposes of PET MPI analysis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Lantheus Medical Imaging

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography		12 months	No
Secondary	Diagnostic performance evaluation of CAD (PETVsSPECT)		12 months	No
Secondary	Diagnositic performance evaluation of multivessel disease (PETvsSPECT)		12 months	No
Secondary	Detection of CAD in subgroups: pharm stress, females and BMI>/=30		12 months	No
Secondary	Image quality of rest and stress (PETvsSPECT)		12 months	No
Secondary	Diagnostic certainty evaluation of rest and stress (PETvsSPECT)		12 months	No
Secondary	Evaluation of reversible defect size of rest and stress (PETvsSPECT)		12 months	No
Secondary	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).		12 months	Yes