| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04594941 | A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes | PHASE2 | COMPLETED | 38 | — | — | Jan 27, 2022 | May 26, 2022 | Aug 1, 2023 | 5 | United States |
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...