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

• Status: Not yet recruiting
• Trial end date: 2021-12-15
• Target enrollment: 0
• Participant gender: All

Summary

This is a Phase 2 prospective, randomized, crossover study of Flurpiridaz (18F) Injection for PET-MPI in subjects 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 subjects will be enrolled in this study and will undergo 2 Flurpiridaz (18F) Injection PET-MPI at rest. Each subject will attend a Screening Visit at least 2 days and up to 14 days prior to the first Flurpiridaz (18F) Injection PET-MPI. The subjects will be randomized 1:1:1:1 to 4 possible sequences of receiving 2 doses of Flurpiridaz (18F) Injection: 2 groups of 7 subjects will receive 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 subjects will be followed up by telephone for adverse events (AEs) and serious AEs (SAEs) at 24 (+8) hours following each Flurpiridaz (18F) Injection administration.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GE Healthcare

Criteria

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.