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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.](streamdown:incomplete-link)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flurpiridaz (18F) Injection | Drug | All participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein at rest. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
* The participant was a man or woman ≥18 years of age
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:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Francois Tranquart, MD, PhD | GE Healthcare | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indago Research and Health Center | Hialeah | Florida | 33012 | United States | ||
| Pioneer Clinical Studies |
A total of 38 participants were enrolled, of which 35 were randomized into 1 of 4 sequences: Solid phase extraction (SPE)-SPE, high performance liquid chromatography (HPLC)-HPLC, SPE-HPLC, HPLC-SPE) to receive either 2 doses of Flurpiridaz (18F) Injection manufactured by the same process (HPLC or SPE) or 2 doses manufactured by different processes (1 dose by HPLC and 1 dose by SPE in a random order).
This study was conducted at 5 centers in the United States from 27 January 2022 and 26 May 2022.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 3, 2022 | Jul 5, 2023 |
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| 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. | Up to 2 weeks |
| 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. | 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. | 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. | 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. | 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. | 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. | 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. | From screening up to end of follow up (up to 30 days) |
| Miami |
| Florida |
| 33155 |
| United States |
| Amavita Clinical Research, LLC | North Miami Beach | Florida | 33169 | United States |
| University of Tennessee Medical Center | Knoxville | Tennessee | 39720 | United States |
| Memorial City and Katy Cardiology Associates | Katy | Texas | 77493 | United States |
| FG001 | 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. |
| FG002 | 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. |
| FG003 | 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. |
| Modified Intent-to-Treat (mITT) Population | mITT population included all participants who were randomized to receive >=1 dose of Flurpiridaz (18F) Injection and who completed the 2 rest Flurpiridaz (18F) Injection PET-MPI procedures. |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment Sequence: SPE-SPE | Participants received 2 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 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant. |
| BG001 | 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. |
| BG002 | 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. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Up to 2 weeks |
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| Primary | 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. | 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 was counted once in each group. | Posted | Least Squares Mean | Standard Error | percentage of score | Up to 2 weeks |
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| Primary | 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. | 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. | Posted | Number | Correlation coefficient of score | Up to 2 weeks |
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| Primary | 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. | 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. | Posted | Number | Correlation coefficient of score | Up to 2 weeks |
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| Secondary | 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. | Analysis was performed on mITT population. Here, "overall number of participants analyzed" signifies the participants with non-missing values receiving 2 doses with the same manufacturing process (either SPE-SPE or HPLC-HPLC). 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 was counted once in each group. | Posted | Number | (units on a scale)/(square root 2) | Up to 2 weeks |
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| Secondary | 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. | 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. | Posted | Number | percentage of participants | Up to 2 weeks |
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| Secondary | 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. | 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. | Posted | Mean | 95% Confidence Interval | Difference of scores | Up to 2 weeks |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | percent | Up to 2 weeks |
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| Secondary | 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. | 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. | Posted | Mean | Standard Deviation | percent | Up to 2 weeks |
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| Secondary | 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. | 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. | Posted | Count of Participants | Participants | Up to 2 weeks |
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| Secondary | 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. | Analysis was performed on mITT population. Here, "overall number of participants analyzed" was the number of participants in MITT population for each treatment group. | Posted | Count of Participants | Participants | Up to 2 weeks |
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| Secondary | 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. | The Safety Population included all participants who received >=1 dose of Flurpiridaz (18F) Injection in the study. Here, "overall number of participants analyzed" signifies those participants who took either one dose of IMP (SPE/HPLC) or two doses. | Posted | Count of Participants | Participants | From screening up to end of follow up (up to 30 days) |
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From screening up to end of follow up (up to 30 days)
The Safety Population included all participants who received >=1 dose of Flurpiridaz (18F) Injection in the study. Participants at risk signifies those participants who took either one dose of IMP (SPE/HPLC) or two doses.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Flurpiridaz (18F): SPE | Participants received either 1 or 2 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 mCi (63 to 93 MBq) for each administration and not exceed a total of 6 mCi (222 MBq) for an individual participant. | 0 | 25 | 0 | 25 | 3 | 25 |
| EG001 | Flurpiridaz (18F): HPLC | Participants received either 1 or 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. | 0 | 27 | 0 | 27 | 1 | 27 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Vomiting | Gastrointestinal disorders | MedDRA 25.0 | Systematic Assessment |
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| Dysgeusia | Nervous system disorders | MedDRA 25.0 | Systematic Assessment |
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| Petechiae | Skin and subcutaneous tissue disorders | MedDRA 25.0 | Systematic Assessment |
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The only disclosure restriction on the PI and/or institution is that the Sponsor can review results communications prior to public release and can restrict communications regarding trial results for a period that is more than 30 days (publications/abstracts) but not to exceed 90 days (patent related issues) from the time submitted to the Sponsor to review. The PI may be asked to remove any Sponsor confidential information and/or delay publication to protect any proprietary information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Francois Tranquart, M.D., Ph.D | GE HealthCare | 447775543206 | francois.tranquart@ge.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 27, 2022 | Jul 5, 2023 | SAP_003.pdf |
Not provided
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D017202 | Myocardial Ischemia |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007267 | Injections |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Reader 2 |
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| Reader 3 |
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SPE VS HPLC: Reader 1 Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect. |
| Mixed-effects model for repeated measure |
| 0.9890 |
| LS Mean Difference |
| -0.015 |
| Standard Error of the Mean |
| 1.109 |
| 2-Sided |
| 90 |
| -1.899 |
| 1.868 |
| Other |
| Reader 2: SPE VS HPLC Reader 2: Analysis was based on Mixed model repeated measures (MMRM) model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect. | Mixed-effects model for repeated measure | 0.3852 | LS Mean Difference | -0.753 | Standard Error of the Mean | 0.854 | 2-Sided | 90 | -2.204 | 0.698 | Other |
| Reader 3: SPE VS HPLC Analysis was based on MMRM model include the median SRS in each dosing period as the dependent variable, with manufacturing process, period, and dosing sequence as fixed effects, and participant nested within sequence as the random effect. | Mixed-effects model for repeated measure | 0.9260 | LS Mean Difference | -0.091 | Standard Error of the Mean | 0.968 | 2-Sided | 90 | -1.735 | 1.554 | Other |
| OG001 | Flurpiridaz (18F): 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. |
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| OG001 | Flurpiridaz (18F): HPLC vs 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. |
| OG002 | Flurpiridaz (18F): SPE vs. HPLC | Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose 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. |
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| OG001 |
| Flurpiridaz (18F): HPLC vs 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. |
| OG002 | Flurpiridaz (18F): SPE vs. HPLC | Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose 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. |
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| OG001 | Flurpiridaz (18F): HPLC vs 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. |
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| OG002 | Flurpiridaz (18F): SPE vs. HPLC | Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose 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. |
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| OG001 |
| Flurpiridaz (18F): HPLC vs 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. |
| OG002 | Flurpiridaz (18F): SPE vs HPLC | Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose 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. |
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| OG002 | Flurpiridaz (18F): SPE vs HPLC | Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose 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. |
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| OG002 | Flurpiridaz (18F): SPE vs HPLC | Participants received 2 IV boluses of Flurpiridaz (18F) Injection manufactured by different processes (1 dose by SPE followed by 1 dose by HPLC or 1 dose by HPLC followed by 1 dose 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. |
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| SPE image was slightly better than HPLC image |
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| SPE image was better than HPLC image |
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| SPE image was slightly better than HPLC image |
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| SPE image was better than HPLC image |
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| SPE image was slightly better than HPLC image |
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| SPE image was better than HPLC image |
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| SPE image was slightly better than HPLC image |
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| SPE image was better than HPLC image |
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| SPE image was slightly better than HPLC image |
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| SPE image was better than HPLC image |
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| 2 images were different |
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| 2 images were different |
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| 2 images were different |
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| 2 images were different |
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| 2 images were different |
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