A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes
Condition: Coronary Artery Disease (CAD); Ischemic Heart Disease
MeSH terms: Coronary Artery Disease; Myocardial Ischemia; Heart Diseases
Intervention: Flurpiridaz (18F) Injection
Intervention description: All participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein at rest.
Phase: Phase 2
Study type: Interventional
Primary purpose: Diagnostic
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Outcomes Assessor)
Enrollment: 38.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This was a Phase 2 prospective, randomized, crossover study of Flurpiridaz (18F) Injection
      for PET-MPI in participants referred for evaluation of known coronary artery disease (CAD) or
      for suspected CAD with intermediate to high pre-test probability (PTP). The objective is to
      assess the difference and variability between 2 sets of rest images synthesized by the same
      or 2 different manufacturing processes. Twenty-eight evaluable [participants were enrolled in
      this study and underwent 2 Flurpiridaz (18F) Injection PET-MPI at rest. Each participant
      attended a Screening Visit at least 2 days and up to 14 days prior to the first Flurpiridaz
      (18F) Injection PET-MPI. The participants were randomized 1:1:1:1 to 4 possible sequences of
      receiving 2 doses of Flurpiridaz (18F) Injection: 2 groups of 7 participants received 2
      Flurpiridaz (18F) Injection doses synthesized by the same manufacturing processes (either
      HPLC or SPE) and 2 groups of 7 subjects will receive 2 Flurpiridaz (18F) Injection doses
      synthesized by different manufacturing processes (1 dose by HPLC followed by 1 dose by SPE or
      1 dose by SPE followed by 1 dose by HPLC). All participants were followed up by telephone for
      adverse events (AEs) and serious AEs (SAEs) at 24 (+8) hours following each Flurpiridaz (18F)
      Injection administration.
    

Eligibility criteria:

        Inclusion Criteria:

          -  * The participant was a man or woman ≥18 years of age

               -  The participant was undergoing evaluation of known CAD or for suspected CAD with
                  an intermediate to high PTP.

               -  The participant had read, signed, and dated an informed consent form (ICF) prior
                  to any study procedures being performed, and was willing to allow the study
                  investigator to make the participant's medical records available to GE
                  Healthcare.

               -  The participant was male or was a nonpregnant, nonlactating female who was either
                  surgically sterile (had a documented bilateral tubal ligation and oophorectomy
                  and/or documented hysterectomy [bilateral tubal ligation alone was insufficient])
                  or was post-menopausal (cessation of menses for more than 1 year); enrollment in
                  the study without a pregnancy test at Screening was allowed for these categories
                  of female participants. 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 participants must have been practicing appropriate birth control
                  from the time of the screening to 30 days after the second radiopharmaceutical
                  administration. Such methods included: 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 participant was able and willing to comply with all study procedures as
                  described in the protocol.

        Exclusion Criteria:

          -  * Participants who were pregnant, may possibly be pregnant, or wish (including their
             partners) to become pregnant during the study period, or were lactating

               -  Participants who were unable to undergo all of the imaging procedures

               -  Participant 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 led to symptoms or hemodynamic compromise.

               -  Participants required 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.

               -  Participants with screening laboratory findings as follows:

                    1. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was
                       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).

               -  Participants who presented 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
                  participants whom the investigator judges to be unsuitable for participation in
                  the study for any reason.

               -  Participants undergone evaluation for heart transplantation or with a history of
                  heart transplantation.

               -  Participants enrolled in another clinical study within the 30 days before
                  enrollment in this study.

               -  Participants previously enrolled in this study or any Flurpiridaz (18F) Injection
                  study.