A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes

Inclusion Criteria:

• * The subject is a man or woman ≥18 years of age

  • The subject is undergoing evaluation of known CAD or for suspected CAD with an intermediate to high PTP.
  • 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.
  • 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); enrollment in the study without a pregnancy test at Screening is allowed for these categories of female subjects. 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 each radiopharmaceutical administration) must be negative. These subjects must be practicing appropriate birth control from the time of the screening to 30 days after the second radiopharmaceutical administration. Such methods include: hormonal contraception including oral contraceptives; intrauterine device; intrauterine hormone releasing system; bilateral tubal occlusion; vasectomized partner; sexual abstinence; adequate barrier method with spermicide (e.g., diaphragm, condom).
  • The subject is able and willing to comply with all study procedures as described in the protocol.

Exclusion Criteria:

• * Subjects who are pregnant, may possibly be pregnant, or wish (including their partners) to become pregnant during the study period, or are lactating

  • Subjects who are unable to undergo all of the imaging procedures

  • Subjects with unstable cardiovascular condition, including but not limited to:

    1. Transient ischemic attack/stroke within 3 months of enrollment;
    2. Significant congenital heart disease;
    3. Uncontrolled hypertension;
    4. Uncontrolled tachyarrhythmia leading to symptoms or hemodynamic compromise.
  • Subjects requiring cardiac intervention (i.e., percutaneous coronary intervention or coronary artery bypass graft) before completing the study.
  • Primary hemodynamically significant uncorrected valvular heart disease, obstructive or regurgitant.

  • Subjects with screening laboratory findings as follows:

    1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 3 times the upper limit of normal;
    2. Total bilirubin ≥2.0 mg/dL (34.2 μmol/L);
    3. Serum creatinine ≥3.0 mg/dL (265.2 μmol/L).
  • Subjects 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 subjects whom the investigator judges to be unsuitable for participation in the study for any reason.
  • Subjects undergoing evaluation for heart transplantation or with a history of heart transplantation.
  • Subjects enrolled in another clinical study within the 30 days before enrollment in this study.
  • Subjects previously enrolled in this study or any Flurpiridaz (18F) Injection study.