This statement is in relation to the current shortage of Ga68 PET radionuclide. This will address the shortage or lack of availability of somatostatin analogue PET agents that we are currently experiencing in many parts of the U.S.” Ga68 PET Shortages explained “Once approved, 64Cu-Dotatate will be available to patients in medical centers with PET capability across the country.
The radionuclide is not new, it’s been in use for some time, mainly in Denmark.Ħ4Cu is a PET isotope that can be produced at a central location in quantities to meet the commercial needs of hospitals and imaging centers without the supply limitations of nuclear generator-based PET isotopes,” said Ebrahim Delpassand, MD, CEO of RadioMedix. This partnership builds on the initial development work conducted by RadioMedix and will benefit from Curium’s regulatory, manufacturing, distribution, and commercial expertise. RadioMedix is currently engaged in Phase III clinical trials of the agent and expects to file a New Drug Application with the Food and Drug Administration in 2019.
announce an exclusive agreement to develop and commercialize 64Cu-Dotatate, an investigational positron emission tomography (PET) diagnostic agent for patients with Neuroendocrine Tumors (NETs). Read more by clicking here.Ĭurium and RadioMedix Inc. Read more here.Įdit : RadioMedix and Curium Announce FDA Fast Track Designation For 64Cu-Dotatate. US FDA announced approval of Ga68 DOTATOC.
NETSPOT IMAGING TRIAL
The objective of this trial is to provide patients with confirmed or suspicion of NET access to Copper Cu 64 Dotatate for the detection, localization, and monitoring of SSTR expressing NETs.Įdit. Expanded Access Program via clinical trial now recruiting – see below.
Majority read revealed Detectnet had over 98% accuracy, 100% sensitivity, and over 96% specificity to confirm or exclude presence of disease. 64Cu-dotatate now named Detectnet™ is approved for use by US FDA. The imaging time window of 64Cu-DOTATATE positron emission tomography/computed tomography (PET/CT) for patients with neuroendocrine neoplasms can be expanded from one hour to three hours post-injection, according to new research published in the January 2021 issue of The Journal of Nuclear Medicine.
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