![]() ![]() These are essential factors for the patient safety and enable the usage of the GalliaPharm® generator for kit labeling for its appropriate medicinal use for PET.Įckert & Ziegler Strahlen- und Medizintechnik AG (ISIN DE0005659700), with approximately 700 employees, is one of the world’s largest providers of isotope technology for radiation therapy and nuclear medicine. GalliaPharm® meets all the strict requirements of the relevant EU pharmacopoeia monograph including sterility over the entire one-year shelf-life and the Ge-68 breakthrough limit (< 0.001%). Completed in a couple hours, this test is much quicker than the onerous three-day octreoscan (which uses a radioactive drug and a gamma camera to measure the radio material over time. ![]() For the USA a Type II Drug Master File (DMF No. This imaging approach significantly improves detection of NETs in three important ways: Faster process. GalliaPharm® is the only Ge-68/Ga-68 generator registered as a medicinal product in several countries of the European Union. With the creation of the Netspot ® Scan, we are better able to find these small tumors quicker and develop more effective treatments from the high-resolution images this procedure provides. Here, we identify the liver as a potential reference region for analyzing NETSPOT images and establish SUVR as a tool which facilitates a semi-quantitative interpretation of 68 Ga-dotatate scans without significant disruptions to established imaging and analysis workflows. This successful kit approval links the Eckert & Ziegler GalliaPharm® Ge-68/Ga-68 generator as the source of the Ga-68 in the kit’s package insert (PI). An Octreoscan is a test that can indicate the extent of small tumors and show where they are located in the body. NETSPOT™ is the first kit approved by the FDA that will utilize the improved imaging enabled by the PET emitting Ga-68, which is conveniently obtained from Eckert & Ziegler Radiopharma’s GalliaPharm® Ge-68/Ga-68 generator. The kit will be used for the labeling of 68Ga-68 dotatate for injection, for the localization of somatostatin receptor positive neuroendocrine tumors in adult and pediatric patients using Positron Emission Tomography (PET). J– Advanced Accelerator Applications (AAA - The radiopharmaceutical company headquartered in SAINT-GENIS-POUILLY, France) have obtained approval from the US FDA for their diagnostic imaging NETSPOT™ Gallium Ga 68 dotatate kit. Whats more, Netspot significantly improves the imaging experience for patients.
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