Clinical trial NCT04594941: A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes
Official title: A Descriptive, Comparative, Randomized, Crossover Study of Flurpiridaz (18F) Injection for Positron Emission Tomography (PET) Imaging for Assessment of Myocardial Perfusion Imaging Quality Using High Performance Liquid Chromatography (HPLC) and Solid Phase Extraction (SPE) Manufacturing Processes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Coronary Artery Disease (CAD)
Ischemic Heart Disease
Lead sponsor: GE Healthcare
Sponsor class: INDUSTRY
First posted: 2020-10-20
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: DIAGNOSTIC

Brief 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.

Primary outcomes:
measure: Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI)
timeFrame: Up to 2 weeks
measure: Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI
timeFrame: Up to 2 weeks
measure: Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation
timeFrame: Up to 2 weeks
measure: Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b
timeFrame: Up to 2 weeks
Secondary outcomes:
measure: Variability of the SRS After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses by the Same Process
timeFrame: Up to 2 weeks
measure: Percentage of Participants With Intra-Reader Agreement of the Detection of Ischemic Defect on PET-MPI at Rest Between 2 MPI Acquisitions Using 2 Flurpiridaz (18F) Injection Doses
timeFrame: Up to 2 weeks
measure: Difference Between the Perfusion Rest Scores for Each of the 17 Segments and Each Reader for 2 Flurpiridaz (18F) Injection Doses From Same and Different Manufacturing Process
timeFrame: Up to 2 weeks
measure: Difference in Standard Uptake Value (SUV) of Time-activity Curves (TACs) by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
timeFrame: Up to 2 weeks
measure: Relative Difference in SUV (5- to 15-minute Perfusion Image) of TACs by Region After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses Synthesized by Same and 2 Different Manufacturing Processes
timeFrame: Up to 2 weeks
measure: Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Different Manufacturing Processes
timeFrame: Up to 2 weeks
measure: Number of Participants Categorized Based on Intra-Reader Agreement of the Image Quality Score Between the 2 Sets of PET Images for 2 Flurpiridaz (18F) Injection Doses From Same Manufacturing Processes
timeFrame: Up to 2 weeks
measure: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
timeFrame: From screening up to end of follow up (up to 30 days)
Other outcomes:
Locations:
city: Hialeah
country: United States
facility: Indago Research and Health Center
state: Florida
city: Miami
country: United States
facility: Pioneer Clinical Studies
state: Florida
city: North Miami Beach
country: United States
facility: Amavita Clinical Research, LLC
state: Florida
city: Knoxville
country: United States
facility: University of Tennessee Medical Center
state: Tennessee
city: Katy
country: United States
facility: Memorial City and Katy Cardiology Associates
state: Texas
Study officials:
affiliation: GE Healthcare
name: Francois Tranquart, MD, PhD
role: STUDY_DIRECTOR
References: