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

May 29, 2013 updated by: Lantheus Medical Imaging

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)

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

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

Interventional

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography
Time Frame: 12 months
12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Diagnostic performance evaluation of CAD (PETVsSPECT)
Time Frame: 12 months
12 months
Diagnositic performance evaluation of multivessel disease (PETvsSPECT)
Time Frame: 12 months
12 months
Detection of CAD in subgroups: pharm stress, females and BMI>/=30
Time Frame: 12 months
12 months
Image quality of rest and stress (PETvsSPECT)
Time Frame: 12 months
12 months
Diagnostic certainty evaluation of rest and stress (PETvsSPECT)
Time Frame: 12 months
12 months
Evaluation of reversible defect size of rest and stress (PETvsSPECT)
Time Frame: 12 months
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
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lantheus Medical Imaging

Investigators

  • Study Director: Cesare Orlandi, MD, Lantheus Medical Imaging

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Anticipated)

February 1, 2014

Study Completion (Anticipated)

May 1, 2014

Study Registration Dates

First Submitted

August 28, 2012

First Submitted That Met QC Criteria

September 5, 2012

First Posted (Estimate)

September 10, 2012

Study Record Updates

Last Update Posted (Estimate)

May 30, 2013

Last Update Submitted That Met QC Criteria

May 29, 2013

Last Verified

April 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BMS747158-302

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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