Coronary Artery Disease (CAD)Phase 2NCT04594941

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

A Phase 2 study testing Flurpiridaz (18F) Injection in people with Coronary Artery Disease (CAD) and Ischemic Heart Disease, run by GE Healthcare at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Coronary Artery Disease (CAD), Ischemic Heart Disease
What is being tested?: Flurpiridaz (18F) Injection
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 5 sitesUnited States
Study dates: 27 Jan 2022to 26 May 2022
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

* 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.

Who cannot join

* 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:
Transient ischemic attack/stroke within 3 months of enrollment;
Significant congenital heart disease;
Uncontrolled hypertension;

Show all 17Show fewer

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:
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) was greater than 3 times the upper limit of normal;
Total bilirubin ≥2.0 mg/dL (34.2 μmol/L);
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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Indago Research and Health Center
Hialeah, Florida, 33012
Memorial City and Katy Cardiology Associates
Katy, Texas, 77493
University of Tennessee Medical Center
Knoxville, Tennessee, 39720
Pioneer Clinical Studies
Miami, Florida, 33155
Amavita Clinical Research, LLC
North Miami Beach, Florida, 33169

Other trials in United States

About this study

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

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
Being tested: Flurpiridaz (18F) Injection
Medical subject headings: Coronary Artery Disease, Myocardial Ischemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04594941
Study group	Role	What they receive
Treatment Sequence: SPE-SPE	Experimental	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. Receives: Drug: Flurpiridaz (18F) Injection
Treatment Sequence: HPLC-HPLC	Experimental	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. Receives: Drug: Flurpiridaz (18F) Injection
Treatment Sequence: SPE-HPLC	Experimental	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. Receives: Drug: Flurpiridaz (18F) Injection
Treatment Sequence: HPLC-SPE	Experimental	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. Receives: Drug: Flurpiridaz (18F) Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI)
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader difference of SRS for PET MPI was reported.
Measured: Up to 2 weeks
Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. Summed score of the 17 segments SRS was used for analysis. SR% is calculated by dividing the SRS by a number corresponding to the SRS value indicating a deficit of 4 in every segment and then multiplying the result by 100. Intra-reader difference of SR% for PET MPI was reported.
Measured: Up to 2 weeks
Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader correlation of SRS for PET MPI assessed using Pearson's correlation was reported.
Measured: Up to 2 weeks
Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader correlation of SRS for PET MPI assessed using Kendall's tau-b was reported.
Measured: Up to 2 weeks

Secondary outcomes (8)

Variability of the SRS After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses by the Same Process
Variability of SRS was estimated by using the SD of the paired difference divided by square root of 2. SRS was used for myocardial perfusion defects examination. The independent reads of all MPI images were based on standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. Variability of the SRS after MPI sessions using 2 Flurpiridaz (18F) injection doses by the same process was reported.
Measured: Up to 2 weeks
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
Percentage of participants with intra-reader agreement of the detected ischemic defect on PET-MPI was reported.
Measured: Up to 2 weeks
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
Perfusion rest score was used for myocardial perfusion defects examination. The independent reads of all MPI images were based on standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal: 0; Minimal, mild impairment of perfusion, ambiguous image: 1; Moderate impairment of perfusion: 2; Significant impairment of perfusion: 3, No perfusion: 4. Higher score indicates impairment. Mean of the paired difference between the perfusion rest scores from 2 manufacturing processes for each of the 17 segments and each reader for 2 Flurpiridaz (18F) injection doses from same and different manufacturing process was reported.
Measured: Up to 2 weeks
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
Difference was calculated by (Mean SUV from the second injection - Mean SUV from the first injection). SUV was calculated as Decay Corrected Uptake (kBq/cc) / (Injected Dose [MBq] / Weight (kilogram [kg]). Difference in SUV of TACs by region after MPI sessions using 2 Flurpiridaz (18F) injection doses synthesized by same and 2 different manufacturing processes was reported.
Measured: Up to 2 weeks
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
Relative difference was calculated as 100 (SUV1-SUV2) / (0.5*[SUV1 + SUV2]) and SUV was calculated as Decay Corrected Uptake (kBq/cc) / (Injected Dose [MBq] / Weight [kg]). Relative difference in SUV of TACs by region after MPI sessions using 2 Flurpiridaz (18F) injection doses synthesized by same and 2 different manufacturing processes was reported.
Measured: Up to 2 weeks
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
Image quality scoring was performed as following: SPE image was worse than HPLC image when the difference (SPE - HPLC) score was less than or equal (<=)-3. SPE image was slightly worse than HPTC image when the difference score was <=-1 and greater than (>)-3. SPE and HPLC images were the same when the difference score was >-1 and less than (<) 1. SPE image was slightly better when the difference score >=1 and <3. SPE image was better when the difference was >=3. Higher score indicates better outcomes. 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 was reported.
Measured: Up to 2 weeks
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
Image quality scoring was performed as following: 2 images were the same when the absolute difference score was >=0 and <1. 2 images were slightly different when the absolute difference score >=1 and <3. 2 images were different when the absolute difference score >=3. Higher score indicates better outcomes. 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 was reported.
Measured: Up to 2 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
A TEAE was defined as an adverse events (AE) that occurred from the time of investigational medicinal product (IMP) administration through the end of the follow-up period for the corresponding dose. Any medication error, clinically significant vital signs, electrocardiograms (ECGs), hematology, clinical chemistry laboratory tests, and urinalysis values determined by investigator were reported as TEAEs. Number of participants with TEAEs and serious TEAEs were reported.
Measured: From screening up to end of follow up (up to 30 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

27 Jan 202226 May 2022

First posted20 Oct 2020
Study start27 Jan 2022
Primary completion26 May 2022
Study completion26 May 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Coronary Artery Disease (CAD)Studies of the same condition, open and under way.
More trials run by GE HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04594941
Sponsor's protocol ID: GE-265-001
Status last verified: Jul 2023
First submitted: 29 Sep 2020
Last updated: 1 Aug 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT04594941
Acronym / sponsor ID: GE-265-001
Conditions: Coronary Artery Disease (CAD), Ischemic Heart Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Study start: 27 Jan 2022 (actual)
Primary completion: 26 May 2022 (actual)
Study completion: 26 May 2022 (actual)
First posted: 20 Oct 2020 (actual)
Results: Posted 1 Aug 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, outcomes assessor)
Number of arms: 4

Arm	Type	Receives
Treatment Sequence: SPE-SPE	Experimental	Drug: Flurpiridaz (18F) InjectionParticipants 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.
Treatment Sequence: HPLC-HPLC	Experimental	Drug: Flurpiridaz (18F) InjectionParticipants 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.
Treatment Sequence: SPE-HPLC	Experimental	Drug: Flurpiridaz (18F) InjectionParticipants 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.
Treatment Sequence: HPLC-SPE	Experimental	Drug: Flurpiridaz (18F) InjectionParticipants 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

* The participant was a man or woman ≥18 years of age

Key exclusion criteria (17 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Flurpiridaz (18F) InjectionAll participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein at rest.	Drug	Treatment Sequence: HPLC-HPLC, Treatment Sequence: HPLC-SPE, Treatment Sequence: SPE-HPLC, Treatment Sequence: SPE-SPE

Primary outcome

Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI)
Time frame: Up to 2 weeks
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader difference of SRS for PET MPI was reported.
Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI
Time frame: Up to 2 weeks
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. Summed score of the 17 segments SRS was used for analysis. SR% is calculated by dividing the SRS by a number corresponding to the SRS value indicating a deficit of 4 in every segment and then multiplying the result by 100. Intra-reader difference of SR% for PET MPI was reported.
Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation
Time frame: Up to 2 weeks
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader correlation of SRS for PET MPI assessed using Pearson's correlation was reported.
Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b
Time frame: Up to 2 weeks
3 qualified readers (independent from the study) performed independent reads of all MPI images, inclusive of standard 17-segment polar-maps of perfusion defects. Each reader scored the perfusion pattern in each segment (17 segments) using a 5-point scale score range from 0 to 4: Normal 0, Minimal, mild impairment of perfusion = 1, Moderate impairment of perfusion = 2, Significant impairment of perfusion = 3, No perfusion = 4. Higher score indicated = impairment of perfusion. SRS was calculated by summing individual scores from each of 17 segments to give an overall score between 0 and 68; a score of 0 indicates normal outcome and scores more than 0 indicate increasingly worse outcomes as the score increases. The summed score of the 17 segments SRS was used for analysis. Intra-reader correlation of SRS for PET MPI assessed using Kendall's tau-b was reported.

8 secondary outcomes

Variability of the SRS After MPI Sessions Using 2 Flurpiridaz (18F) Injection Doses by the Same Process
Time frame: Up to 2 weeks
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
Time frame: Up to 2 weeks
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
Time frame: Up to 2 weeks
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
Time frame: Up to 2 weeks
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
Time frame: Up to 2 weeks
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
Time frame: Up to 2 weeks
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
Time frame: Up to 2 weeks
Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: From screening up to end of follow up (up to 30 days)

Results and safety

Results posted to the registry on 1 Aug 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment Sequence: SPE-SPE	7	7
Treatment Sequence: HPLC-HPLC	10	7
Treatment Sequence: SPE-HPLC	11	10
Treatment Sequence: HPLC-SPE	7	7

Primary outcome: Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI)

Time frame: Up to 2 weeks. Least squares mean (Standard Error). Unit: score on a scale

Measure	Flurpiridaz (18F): SPE n = 31	Flurpiridaz (18F): HPLC n = 31
Median of Readers	6.662 (1.818)	6.513 (1.818)
Reader 1	6.235 (1.846)	6.219 (1.846)
Reader 2	7.009 (2.056)	6.256 (2.056)
Reader 3	7.336 (1.831)	7.246 (1.831)

Flurpiridaz (18F): SPE vs Flurpiridaz (18F): HPLC: Least Sqaure (LS) Mean Difference: -0.149 (90% CI -1.431 to 1.133), p = 0.8452, Mixed-effects model for repeated measure
Flurpiridaz (18F): SPE vs Flurpiridaz (18F): HPLC: LS Mean Difference: -0.015 (90% CI -1.899 to 1.868), p = 0.9890, Mixed-effects model for repeated measure
Flurpiridaz (18F): SPE vs Flurpiridaz (18F): HPLC: LS Mean Difference: -0.753 (90% CI -2.204 to 0.698), p = 0.3852, Mixed-effects model for repeated measure

Population analysed: Analysis was performed on mITT population. A participant received SPE in both periods was counted twice in SPE group and a participant received HPLC in both periods was counted twice in HPLC group, while a participant received both methods is counted once in each group.

Primary outcome: Intra-reader Difference of Summed Rest Percent (SR%) for PET MPI

Time frame: Up to 2 weeks. Least squares mean (Standard Error). Unit: percentage of score

Measure	Flurpiridaz (18F): SPE n = 31	Flurpiridaz (18F): HPLC n = 31
Median of Readers	9.797 (2.673)	9.578 (2.673)
Reader 1	9.168 (2.714)	9.146 (2.714)
Reader 2	10.307 (3.023)	9.200 (3.023)
Reader 3	10.789 (2.692)	10.655 (2.692)

Flurpiridaz (18F): SPE vs Flurpiridaz (18F): HPLC: LS Mean Difference: -0.219 (90% CI -2.104 to 1.667), p = 0.8452, Mixed-effects model for repeated measure
Flurpiridaz (18F): SPE vs Flurpiridaz (18F): HPLC: Least Square Mean (LSM) Difference: -0.023 (90% CI -2.793 to 2.747), p = 0.9890, Mixed-effects model for repeated measure
Flurpiridaz (18F): SPE vs Flurpiridaz (18F): HPLC: LS Mean Difference: -1.107 (90% CI -3.241 to 1.027), p = 0.3852, Mixed-effects model for repeated measure

Primary outcome: Intra-reader Correlation of SRS for PET MPI: Pearson's Correlation

Time frame: Up to 2 weeks. Number. Unit: Correlation coefficient of score

Measure	Flurpiridaz (18F): SPE vs SPE n = 7	Flurpiridaz (18F): HPLC vs HPLC n = 7	Flurpiridaz (18F): SPE vs. HPLC n = 17
Reader 1	1.000	0.890	0.787
Reader 2	0.997	0.905	0.881
Reader 3	0.999	0.931	0.910

Flurpiridaz (18F): SPE vs SPE: p <0.0001, Wilcoxon Signed Rank Test
Flurpiridaz (18F): SPE vs SPE: p <0.0001, Wilcoxon Signed Rank Test
Flurpiridaz (18F): SPE vs SPE: p <0.0001, Wilcoxon Signed Rank Test

Population analysed: Analysis was performed on mITT population. SPE vs. HPLC was either SPE followed by HPLC or HPLC followed by SPE as a treatment sequence. Here, "overall number of participants analyzed" was the number of participants in MITT population for each treatment group.

Primary outcome: Intra-reader Correlation of SRS for PET MPI: Kendall's Tau-b

Time frame: Up to 2 weeks. Number. Unit: Correlation coefficient of score

Measure	Flurpiridaz (18F): SPE vs SPE n = 7	Flurpiridaz (18F): HPLC vs HPLC n = 7	Flurpiridaz (18F): SPE vs. HPLC n = 17
Reader 1	1.000	0.732	0.769
Reader 2	0.856	0.872	0.869
Reader 3	1.000	0.733	0.833

Flurpiridaz (18F): SPE vs SPE: p = 0.0089, Wilcoxon Signed Rank Test
Flurpiridaz (18F): SPE vs SPE: p = 0.0207, Wilcoxon Signed Rank Test
Flurpiridaz (18F): SPE vs SPE: p = 0.0089, Wilcoxon Signed Rank Test

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: From screening up to end of follow up (up to 30 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Flurpiridaz (18F): SPE	0 of 25 (0%)	3 of 25 (12%)	0 of 25
Flurpiridaz (18F): HPLC	0 of 27 (0%)	1 of 27 (3.7%)	0 of 27

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Francois Tranquart, MD, PhD study director

GE Healthcare

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Flurpiridaz (18F) Injection in people with Coronary Artery Disease (CAD) and Ischemic Heart Disease, run by GE Healthcare at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intra-reader Difference of Summed Rest Score (SRS) for Positron Emission Tomography (PET) Myocardial Perfusion Imaging (MPI) (time frame: Up to 2 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04594941.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2023.