A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With Coronary Artery Disease (CAD)

This study has been withdrawn prior to enrollment.

Sponsor:

Information provided by (Responsible Party):

Lantheus Medical Imaging

ClinicalTrials.gov Identifier:

NCT01681524

First received: August 28, 2012

Last updated: April 2, 2013

Last verified: April 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

August 28, 2012

Last Updated Date

April 2, 2013

Start Date ^ICMJE

November 2012

Estimated Primary Completion Date

February 2014 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01681524 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With Coronary Artery Disease (CAD)

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

Phase 3

Study Design ^ICMJE

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

Condition ^ICMJE

Coronary Artery Disease

Intervention ^ICMJE

Drug: Flurpiridaz F18 Injection

Injection of Flurpiridaz F18 for the purposes of PET MPI analysis

Study Arm (s)

Experimental: 1

Investigational product will compare images from PET and SPECT cameras.

Intervention: Drug: Flurpiridaz F18 Injection

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

Enrollment ^ICMJE

Estimated Completion Date

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Not Provided

Administrative Information

NCT Number ^ICMJE

NCT01681524

Other Study ID Numbers ^ICMJE

BMS747158-302

Has Data Monitoring Committee

Yes

Responsible Party

Lantheus Medical Imaging

Study Sponsor ^ICMJE

Lantheus Medical Imaging

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Simon P Robinson, PhD

Lantheus Medical Imaging

Information Provided By

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

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