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

NCT ID: NCT04594941

Last Updated: 2023-08-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 38 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-27
• Study Completion Date: 2022-05-26

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.

Conditions

Coronary Artery Disease (CAD); Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

Treatment Sequence: SPE-SPE

Participants received 2 intravenous (IV) boluses of Flurpiridaz (18F) Injection manufactured by SPE process at Visit 1 and 2.

The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 millicurie (mCi) (63 to 93 megabecquerel [MBq]) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.

Group Type: EXPERIMENTAL

Flurpiridaz (18F) Injection

Intervention Type: DRUG

All participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein at rest.

Treatment Sequence: HPLC-HPLC

Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by HPLC process at Visit 1 and 2.

The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.

Group Type: EXPERIMENTAL

Flurpiridaz (18F) Injection

Intervention Type: DRUG

All participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein at rest.

Treatment Sequence: SPE-HPLC

Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by 2 different processes (1 dose manufactured by SPE followed by 1 dose manufactured by HPLC) at Visit 1 and 2.

The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.

Group Type: EXPERIMENTAL

Flurpiridaz (18F) Injection

Intervention Type: DRUG

All participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein at rest.

Treatment Sequence: HPLC-SPE

Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by 2 different processes (1 dose manufactured by HPLC followed by 1 dose manufactured by SPE) at Visit 1 and 2.

The targeted dose to the body of Flurpiridaz (18F) Injection was to be in the range of 1.7 to 2.5 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant.

Group Type: EXPERIMENTAL

Flurpiridaz (18F) Injection

Intervention Type: DRUG

All participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein at rest.

Interventions

Flurpiridaz (18F) Injection

All participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein at rest.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GE Healthcare

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Francois Tranquart, MD, PhD

Role: STUDY_DIRECTOR

GE Healthcare

Locations

Indago Research and Health Center

Hialeah, Florida, United States

Pioneer Clinical Studies

Miami, Florida, United States

Amavita Clinical Research, LLC

North Miami Beach, Florida, United States

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Memorial City and Katy Cardiology Associates

Katy, Texas, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

GE-265-001

Identifier Type: -

Identifier Source: org_study_id