CLINICAL TRIALS PROFILE FOR FLURPIRIDAZ F-18
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All Clinical Trials for FLURPIRIDAZ F-18
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT01347710 ↗ | A Phase 3 Multi-center Study to Assess PET Imaging of Flurpiridaz F 18 Injection in Patients With CAD. | Completed | Lantheus Medical Imaging | Phase 3 | 2011-06-01 | The primary objective of the study is to assess the diagnostic efficacy (specificity and sensitivity) of flurpiridaz F18 injection PET myocardial perfusion imaging (MPI) compared to single photon emission computed tomography (SPECT) MPI in the detection of significant coronary artery disease (CAD) as defined by invasive coronary angiography (ICA) or a documented history of Myocardial Infarction (MI). |
| NCT01681524 ↗ | Open Label Study to Access Flurpiridaz F18 in PET MPI Verses SPECT MPI | Withdrawn | Lantheus Medical Imaging | Phase 3 | 2012-11-01 | The study will evaluate the use of Flurpiridaz F18 injection in patients with CAD to determine if the study drug in PET imaging is better than SPECT imaging currently used for this purpose. |
| NCT03354273 ↗ | An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD) | Recruiting | Pharmaceutical Product Development, LLC | Phase 3 | 2018-06-08 | This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD. |
| NCT03354273 ↗ | An International Study to Evaluate Diagnostic Efficacy of Flurpiridaz (18F) Injection PET MPI in the Detection of Coronary Artery Disease (CAD) | Recruiting | GE Healthcare | Phase 3 | 2018-06-08 | This is a Phase 3, prospective, open-label, international, multicentre study of Flurpiridaz (18F) Injection for PET MPI in patients referred for ICA because of suspected CAD. |
| NCT04594941 ↗ | A Study of Flurpiridaz (18F) Injection for PET Imaging for Assessment of MPI Quality Using HPLC and SPE Manufacturing Processes | Not yet recruiting | GE Healthcare | Phase 2 | 2021-09-15 | This is a Phase 2 prospective, randomized, crossover study of Flurpiridaz (18F) Injection for PET-MPI in subjects 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 subjects will be enrolled in this study and will undergo 2 Flurpiridaz (18F) Injection PET-MPI at rest. Each subject will attend a Screening Visit at least 2 days and up to 14 days prior to the first Flurpiridaz (18F) Injection PET-MPI. The subjects will be randomized 1:1:1:1 to 4 possible sequences of receiving 2 doses of Flurpiridaz (18F) Injection: 2 groups of 7 subjects will receive 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 subjects will be followed up by telephone for adverse events (AEs) and serious AEs (SAEs) at 24 (+8) hours following each Flurpiridaz (18F) Injection administration. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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