Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Flurpiridaz · 1 trial · 2 indications
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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 |
|---|---|---|
| Flurpiridaz (18F) Injection | DRUG | All participants received 2 IV boluses of Flurpiridaz (18F) Injection in a large peripheral vein at rest. |
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 procedure...
Flurpiridaz is a small molecule being developed for use in coronary artery disease (CAD) and ischemic heart disease. It is an investigational diagnostic agent intended for PET imaging to assess myocardial perfusion quality. It is currently in Phase 2 clinical development and is not yet approved.
Flurpiridaz is a small molecule used for PET imaging in coronary artery disease. It is designed to assess myocardial perfusion, helping to evaluate blood flow to the heart muscle. The specific molecular target is not disclosed in the available information.
Flurpiridaz is being developed by GE HealthCare Technologies Inc., a company publicly traded under the ticker GEHC. The company is conducting clinical trials to evaluate the drug for use in coronary artery disease and ischemic heart disease.
Flurpiridaz is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. One Phase 2 trial has been completed, and the drug is being studied for use in coronary artery disease and ischemic heart disease.
Flurpiridaz has one completed Phase 2 clinical trial, identified as NCT04594941. This study evaluated Flurpiridaz (18F) Injection for PET imaging to assess myocardial perfusion quality using HPLC and SPE manufacturing processes. The trial enrolled 38 participants in the United States and was randomized, double-blind, and controlled.
Flurpiridaz is a diagnostic imaging agent being developed for coronary artery disease. While it is sometimes referred to as Flurpiridaz F 18, the available information does not list alternative names. The drug is currently in Phase 2 trials and is not yet approved.