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Blue Earth Diagnostics Announces Dosing of Initial Patient in Phase 3 REVELATE Clinical Trial of 18F-Fluciclovine PET Imaging for Detection of Recurrent Brain Metastases

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- Clinical utility of Axumin (fluciclovine F 18) being investigated in expanded areas of cancer imaging -
Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative PET radiopharmaceuticals, today announced that the first patient has been dosed in its Phase 3 REVELATE clinical trial of
18F-fluciclovine, a positron emission tomography (PET) imaging radiopharmaceutical being studied for potential use in detecting recurrent brain metastases. The REVELATE study is a Phase 3, multi-center, single-arm imaging study being conducted in the United States. Its purpose is to assess the diagnostic performance of
18F-fluciclovine PET in detecting recurrent brain metastases in patients previously treated with radiation therapy. The first patient dosed in the study was at Yale University, New Haven, Conn., under the auspices of Dr. Mariam Aboian, Assistant Professor of Radiology. ....

United States , United Kingdom , Samuelt Chao , Mariam Aboian , Peter Gardiner , Priscilla Harlan , Jonathan Allis , Kostenloser Wertpapierhandel , Clare Gidley , Mike Beyer , Yale University , Emory University , Drug Administration , Emory University Department Of Radiology , Sam Brown Inc , Bracco Group , Nuclear Medicine , Corporate Communications , European Union , Imaging Sciences , Department Of Radiation Oncology , Ge Healthcare , Earth Diagnostics , New Haven , Assistant Professor , Blue Earth Diagnostics ,

NorthStar Medical Radioisotopes Announces FDA Approval for Enhanced U.S. Mo-99 Radioisotope Production Capacity

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NorthStar Medical Radioisotopes, LLC, a global innovator in the production and distribution of radiopharmaceuticals used for medical imaging and therapeutic treatments, today announced that the U.S. Food and Drug Administration (FDA) has approved its application for producing Mo-99 from concentrated Mo-98 (cMo-98) and related software updates for the RadioGenix® System (technetium Tc 99m generator). Processing of cMo-98 targets increases production capacity of the important medical radioisotope, molybdenum-99 (Mo-99), up to four times above that of current NorthStar technology, and enables NorthStar to provide customers with higher activity source vessels, which will support enhanced radiopharmacy efficiencies. FDA approval was granted through a Prior Approval Supplement (PAS) to NorthStar’s original RadioGenix® System (technetium Tc 99m generator) New Drug Application, which was approved in 20 ....

United States , Paul Estrem , Stephen Merrick , Alisa Holst , Jamest Harvey , Priscilla Harlan , University Of Missouri Research Reactor , Drug Administration , Northstar Medical Radioisotopes , Prior Approval Supplement , New Drug Application , Radiogenix System , Star Medical Radioisotopes , Business Wire , Missouri Research Reactor , Chief Executive Officer , Beyond Use Date , Isotope Processing , Accelerator Production , Senior Vice President , Chief Science Officer , Important Risk Information , Salivary Gland Imaging , Nasolacrimal Drainage System Imaging , Thyroid Imaging , Vesicoureteral Imaging ,