Ga-68-PSMA-11approvalFDAnew drug applicationThe University of California Los Angeles (UCLA) and University of California San Francisco (UCSF) codeveloped Ga-68-PSMA-11 by conducting a bicentric pivotal phase 3 clinical trial for PET imaging for prostate cancer. On December 1, 2020, 2 separate...
通过注射给药后,Ga 68 PSMA-11能够与PSMA结合,PSMA是前列腺癌成像的重要药理学靶点,在前列腺癌细胞通常高水平表达。作为一种发射正电子的放射性药物,Ga 68 PSMA-11可以通过PET成像,指示机体组织中存在的PSMA阳性前列腺癌病灶。 2项前瞻性临床试验评估了Ga 68 PSMA-11的安全性和疗效。在第一项试验中,325例前列腺...
TLX591-CDx是一种辅助制备镓-68gozetotide注射剂的试剂盒。 前列腺癌成像产品TLX591-CDx(Illuccix),旨在帮助制备镓-68(68Ga)gozetotide注射剂(PSMA-11)的试剂盒,已获得FDA批准,使基于68Ga的前列腺特异性膜抗原(PSMA)-PET的使用更容易 TLX591-CDx是FDA批准的首个商用产品,将扩大美国境内有资格接受68ga-PSMA-PE...
Ga 68 PSMA-11 is a radiopharmaceutical agent used in the diagnosis of prostate-specific membrane antigen (PSMA) positive lesions in male patients during positron emission tomography.
However, due to the existing FDA approval, other hospitals in the US might apply for an abbreviated NDA (new drug application) approval in an accelerated process [31]. 2. Chemical Overview 2.1. Names and Chemical Structure of [68Ga]Ga-PSMA-11 Another name for [68Ga]Ga-PSMA-11 is [68...
Impact of 68Ga-PSMA-11 PET on the management of biochemically recurrent prostate cancer in a prospective single-arm clinical trial. J. Clin. Oncol. 2020, 38. [Google Scholar] [CrossRef] US Food and Drug Administration. FDA Approves 11C-Choline for PET in Prostate Cancer. J. Nucl. Med. ...
62 Background: PET/CT using Ga-68 PSMA-11, which received FDA approval, can detect early biochemical recurrence of prostate cancer at greater sensitivity than conventional imaging, as well as more accurately clinical stage and impact treatment management, particularly vital for high-risk patients. ...
The decision by the FDA to approve prostate cancer imaging product TLX591-CDx, a kit to aid in the preparation of gallium-68 gozetotide injections, should make 68Ga-based PSMA-PET more broadly accessible. Prostate cancer imaging product TLX591-CDx (Illuccix), a kit in...
PSMA-PET shows diagnostic accuracy in initial staging of prostate cancer Hannah Clarke The investigators found a positive correlation between PSA levels and SUVmax. June 23rd 2023 Dr. Schuster highlights the FDA approval of imaging agent flot...
Ga-68 PSMA-11 impacting prostate cancer management in a real-world setting: A pilot experience using the total-body PET/CT scanner. 62 Background: PET/CT using Ga-68 PSMA-11, which received FDA approval, can detect early biochemical recurrence of prostate cancer at greater sensitivity than co...