WebSep 29, 2024 · The FDA has accepted a new drug application (NDA) for the radiohybrid PSMA-PET imaging agent 18 F-rhPSMA-7.3for diagnostic imaging of prostate cancer, according to Blue Earth Diagnostic, the developer of the agent. 1 The NDA is supported by findings from a phase 1 trial and two phase 3 trials, SPOTLIGHT and LIGHTHOUSE. WebFeb 15, 2024 · Blue Earth Diagnostics has two Phase 3 clinical studies evaluating the safety and diagnostic performance of 18 F-rhPSMA-7.3 PET imaging in prostate cancer: (“SPOTLIGHT,” NCT04186845 ), in...

Imaging Study to Investigate the Safety and Diagnostic …

WebApr 10, 2024 · Support of Blue Earth Diagnostics Ltd for providing the 18 F-Fluciclovine and 18 F-rh-PSMA tracers is acknowledged. The funders had no role in study design, data collection and analysis, decision ... WebOct 18, 2024 · Blue Earth Diagnostics Announces Data-sharing Agreement with Siemens Healthineers and the University Hospital of Technical University of Munich (TUM) for 18F-rhPSMA-7.3, an Investigational... circumference and arc length answers

Landscape of prostate-specific membrane antigen …

WebApr 10, 2024 · Support from NIH R35 CA232130, DOD-IDEA Award Grant W81XWH-19-1-0536 and National Cancer Center is acknowledged. Support of Blue Earth Diagnostics Ltd for providing the 18 F-Fluciclovine and 18 F-rh-PSMA tracers is acknowledged. The funders had no role in study design, data collection and analysis, decision to publish or … WebApr 7, 2024 · The US FDA has accepted Blue Earth Diagnostics’ New Drug Application for 18 F-rhPSMA-7.3, an investigational radiohybrid Prostate-Specific Membrane Antigen-targeted (PSMA) PET imaging agent. WebApr 19, 2024 · Prostate-Specific Membrane Antigen (PSMA)-positron emission tomography (PET) is a more sensitive imaging tool compared with CIM, detecting previously CIM-invisible disease (micrometastases). 2, 3 PET radiotracers and PSMA-PET development are discussed in the Data Supplement. diamondhunt2 gold for sale