- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01681524
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
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
16 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
|
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
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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