Coronary Artery DiseasePhase 3NCT01681524
Open Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI
A Phase 3 study testing Flurpiridaz F18 in people with Coronary Artery Disease, run by Lantheus Medical Imaging.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Flurpiridaz F18
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Nov 2012to May 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Invasive Coronary Angiography Men or Women age 18 or older - see protocol for additional details
Who cannot join
- 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
About this study
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)
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.
Read the 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).
- Conditions
- Coronary Artery Disease
- Being tested
- Flurpiridaz F18
- Keywords
- 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
- Medical subject headings
- Coronary Artery Disease, Coronary Disease, Heart Diseases, Cardiovascular Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flurpiridaz F18Drug
Injection of Flurpiridaz F18 for the purposes of PET MPI analysis
| Study group | Role | What they receive |
|---|---|---|
| Flurpiridaz F18 | Experimental | 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 Receives: Drug: Flurpiridaz F18 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography
Measured: 12 months
Secondary outcomes (7)
Diagnostic performance evaluation of CAD (PETVsSPECT)
Measured: 12 months
Diagnositic performance evaluation of multivessel disease (PETvsSPECT)
Measured: 12 months
Detection of CAD in subgroups: pharm stress, females and BMI>/=30
Measured: 12 months
Image quality of rest and stress (PETvsSPECT)
Measured: 12 months
Diagnostic certainty evaluation of rest and stress (PETvsSPECT)
Measured: 12 months
Evaluation of reversible defect size of rest and stress (PETvsSPECT)
Measured: 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).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startNov 2012
- Primary completionFeb 2014 (estimated)
- Study completionMay 2014 (estimated)
Why it stopped: delayed study start
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lantheus Medical Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cesare Orlandi, MD, Study director, Lantheus Medical Imaging
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01681524
- Sponsor's protocol ID
- BMS747158-302
- Status last verified
- Apr 2013
- First submitted
- 28 Aug 2012
- Last updated
- 30 May 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT01681524
- Acronym / sponsor ID
- BMS747158-302
- Conditions
- Coronary Artery Disease
- Keywords
- 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
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: delayed study start
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Lantheus Medical ImagingIndustry (pharma, biotech, devices)
- Study start
- Nov 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- May 2014 (estimated)
- First posted
- 10 Sep 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Flurpiridaz F18 | Experimental | Drug: Flurpiridaz F18Open-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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Invasive Coronary Angiography Men or Women age 18 or older - see protocol for additional details
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Flurpiridaz F18Injection of Flurpiridaz F18 for the purposes of PET MPI analysis | Drug | Flurpiridaz F18 |
Primary outcome
Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography
Time frame: 12 months
7 secondary outcomes
Diagnostic performance evaluation of CAD (PETVsSPECT)
Time frame: 12 months
Diagnositic performance evaluation of multivessel disease (PETvsSPECT)
Time frame: 12 months
Detection of CAD in subgroups: pharm stress, females and BMI>/=30
Time frame: 12 months
Image quality of rest and stress (PETvsSPECT)
Time frame: 12 months
Diagnostic certainty evaluation of rest and stress (PETvsSPECT)
Time frame: 12 months
Evaluation of reversible defect size of rest and stress (PETvsSPECT)
Time frame: 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
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cesare Orlandi, MD study director
Lantheus Medical Imaging
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Flurpiridaz F18 in people with Coronary Artery Disease, run by Lantheus Medical Imaging.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 May 2013. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blinded Image assessment for PET & SPECT perfusion and for interventional coronary angiography (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2013.