Assessment of myocardial perfusion using Positron Emission Tomography (PET) imaging of Flurpiridaz (F 18) Injection in patients with suspected coronary artery disease. MedDRA version: 20.1 Level: LLT Classification code 10028603 Term: Myocardial perfusion scan System Organ Class: 100000004848
Conditions
Interventions
Product Name: Flurpiridaz (F 18) Injection
Pharmaceutical Form: Solution for injection
INN or Proposed INN: Flurpiridaz F18
CAS Number: 863887-89-2
Current Sponsor code: [18F]GEH200458
Other descripti
Sponsors
GE Healthcare Ltd. and its Affiliates
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The subject is a man or woman =18 years of age. 2) The subject has read, signed, and dated an informed consent form (ICF) prior to any study procedures being performed, and is willing to allow the study investigator to make the subject’s medical records available to GE Healthcare (including clinically indicated SPECT studies occurring prior to the signing of the ICF as stipulated in inclusion criteria #4). 3) At the time of enrolment, the subject has been scheduled via written documentation to undergo an ICA for the assessment of CAD. 4) The subject has undergone a clinically indicated SPECT which meets all study-specific imaging and stress testing criteria and conforms to local guidelines (such as American Society of Nuclear Cardiology or European Association of Nuclear Medicine). 5) The subject is male or is a nonpregnant, nonlactating female who is either surgically sterile (has a documented bilateral tubal ligation and oophorectomy and/or documented hysterectomy [bilateral tubal ligation alone is insufficient]) or is post-menopausal (cessation of menses for more than 1 year); enrolment in the study without a pregnancy test at Screening is allowed for these categories of female patients. For women of childbearing potential, the results of either a urine or serum human chorionic gonadotropin pregnancy test (with the result known on the day of radiopharmaceutical administration) must be negative; these subjects must be practicing highly effective contraceptive measures from the time of the screening to 30 days after the radiopharmaceutical administration. For male subjects, condoms should be used from date of exposure to Flurpiridaz (18F) Injection and for a further 90 days post-exposure. 6) The subject is able and willing to comply with all study procedures as described in the protocol. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 390 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 260
Exclusion criteria
Exclusion criteria: 1) Patients who are pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating. 2) Patients who are unable to undergo all of the imaging procedures. 3) Patients who have an established diagnosis of CAD as confirmed by any of the following: a. Previous myocardial infarction (MI); b. Previous cardiac catheter angiography showing =50% stenosis; c. Previous coronary revascularisation, such as percutaneous coronary intervention (PCI), thrombolysis or coronary artery bypass graft (CABG) placement. 4) Patients incapable of undergoing either exercise or pharmacological cardiac stress testing 5) Patients who have a current illness or pathology that, in the opinion of the investigator, would pose a significant safety risk for the patient during cardiac stress testing. 6) For patients for whom pharmacological stress testing is being considered, the following additional exclusion criteria will apply: a. Known hypersensitivity to adenosine, regadenoson, dipyridamole, or aminophylline; b. Use of a caffeinated substance, dipyridamole-containing medication, or methylxanthine-containing medication within 12 hours prior to vasodilator administration; c. Bronchoconstrictive or bronchospastic disease that in the opinion of the investigator poses a significant safety risk for the patient; d. Second- or third-degree atrioventricular block or sinus node dysfunction without functioning artificial pacemaker; e. Any additional contraindication to the pharmacological stress agent listed in the product’s package insert/summary of product characteristics (SmPCs). 7) Patients with unstable cardiovascular condition, including but not limited to: a. Unstable angina, acute coronary syndrome within 6 months of enrolment; b. Transient ischaemic attack/stroke within 3 months of enrolment; c. Significant congenital heart disease; d. Uncontrolled hypertension; e. Uncontrolled tachyarrhythmia leading to symptoms or haemodynamic compromise. 8) Documented history of heart failure and/or cardiomyopathy (including nonischaemic cardiomyopathy, hypertrophic obstructive cardiomyopathy, or infiltrative cardiomyopathy) . 9) Primary haemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant. 10) Patients scheduled for or planning to undergo any cardiac interventional procedures between enrolment and ICA. 11) Patients with screening laboratory findings as follows: a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal; b. Total bilirubin =2.0 mg/dL (34.2 µmol/L); c. Serum creatinine =3.0 mg/dL (265.2 µmol/L). 12) Patients who present with any clinically active, serious, life-threatening disease, medical, or psychiatric condition, and/or who have a life expectancy of <6 months, or for whom study participation may compromise their management; and patients whom the investigator judges to be unsuitable for participation in the study for any reason. 13) Patients undergoing evaluation for heart transplantation or with history of heart transplantation. 14) Patients enrolled in another clinical study within the 30 days prior to being enrolled in this study or scheduled to participate in another clinical study during the 17-day follow-up period of this study. 15) Patients previously enrolled in this study or any Flurpiridaz (F 18) Injection study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Assess the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz (F 18) Injection PET myocardial perfusion imaging (MPI) in the detection of significant CAD, as defined by invasive coronary angiography (ICA), in patients with suspected CAD. ;Secondary Objective: • Evaluate the diagnostic efficacy (sensitivity and specificity) of Flurpiridaz (F 18) Injection PET MPI compared with that of single photon emission computed tomography (SPECT) MPI in the detection of CAD, as defined by ICA, in the following groups of subjects: - All subjects (key secondary endpoint) - Female subjects - Subjects with body mass index (BMI) =30 kg/m2 - Diabetic subjects • Assess the safety of Flurpiridaz (F 18) Injection PET MPI. ;Primary end point(s): The sensitivity and specificity of Flurpiridaz (18 F) Injection PET MPI in the detection of significant CAD as defined by cardiac catheterisation (ICA). Subjects will be considered to have CAD if QCA reveals =50% stenosis of =1 major coronary artery or major branch.;Timepoint(s) of evaluation of this end point: Three qualified independent readers will perform a blinded assessment of each subject’s PET image pair (rest and stress images) and each subject’s SPECT image pair. One blinded reviewer will perform QCA for all ICA images. The data used for the image reads are captured within about 30 minutes of drug administration. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The diagnostic efficacy (sensitivity and specificity) of Flurpiridaz (F 18) Injection PET MPI compared to that of SPECT MPI, when the diagnosis of CAD by ICA is the standard of truth, in the following: - All subjects (key secondary endpoint) - Female subjects - Subjects with BMI =30 kg/m2 - Diabetic subjects;Timepoint(s) of evaluation of this end point: Following Flurpiridaz (18 F) Injection administration and after ICA. Three qualified readers (independent from the study) will perform independ. reads of all MPI images. The PET MPI and SPECT MPI reads will be performed by the same set of readers in cross-over sessions independ. of one another. In each session, PET and SPECT images will be displayed in randomised order, nonsequentially, with PET and SPECT MPI exams corresponding to individual subjects randomly allotted into reading session batches. For each modality, perfusion and gated acquisitions of rest and stress images will be rated for image quality and reviewed. After the results of each individual MPI (PET or SPECT) are locked as “blinded” read. The data used for image reads are captured within about 30 min of drug administration. | — |
Countries
Canada, Finland, France, Germany, Italy, Netherlands, Switzerland, United States
Contacts
Public ContactActing Medical Director
GE Healthcare Ltd.
Outcome results
None listed