Lantheus Announces PYLARIFY AI™ is Now Available
PYLARIFY AI is an FDA-cleared artificial intelligence platform developed to assist in standardized quantification of PSMA PET/CT scans
San Francisco, CA (UroToday.com) -- Lantheus Holdings, Inc., an established leader and fully integrated provider committed to innovative imaging diagnostics, targeted therapeutics, and artificial intelligence solutions to find, fight and follow serious medical conditions, announced that PYLARIFY AI™, its recently FDA-cleared medical device software, is now commercially available in the United States. Read More
Analytical performance of aPROMISE: automated anatomic contextualization, detection, and quantification of [18F]DCFPyL (PSMA) imaging for standardized reporting.
The application of automated image analyses could improve and facilitate standardization and consistency of quantification in [18F]DCFPyL (PSMA) PET/CT scans. In the current study, we analytically validated aPROMISE, a software as a medical device that segments organs in low-dose CT images with deep learning, and subsequently detects and quantifies potential pathological lesions in PSMA PET/CT.
Lantheus Announces the First and Only FDA Cleared AI-Enabled PSMA Digital Application, aPROMISE™
aPROMISE was developed to quantify and standardize assessment of PSMA PET/CT images and will support PYLARIFY® (piflufolastat F 18) adoption in the U.S.
San Francisco, CA (UroToday.com) -- Lantheus Holdings, Inc. (Lantheus) announced that its subsidiary, EXINI Diagnostics AB, was granted 510(k) clearance by the U.S. Food and Drug Administration (FDA) for its digital application, aPROMISE™ (a
state Cancer M
valuation). Read More
A Phase 2/3 Prospective Multicenter Study of the Diagnostic Accuracy of Prostate-Specific Membrane Antigen PET/CT with 18F-DCFPyL in Prostate Cancer Patients (OSPREY).
PSMA-targeted PET/CT has the potential to improve the detection and localization of prostate cancer (PCa). OSPREY was a prospective trial designed to determine the diagnostic performance of 18F-DCFPyL-PET/CT for detecting sites of metastatic PCa.
Diagnostic Performance of 18F-DCFPyL-PET/CT in Men with Biochemically Recurrent Prostate Cancer: Results from the CONDOR Phase 3, Multicenter Study
PURPOSE: Current FDA-approved imaging modalities are inadequate for localizing prostate cancer biochemical recurrence (BCR). 18
F-DCFPyL is a highly selective, small-molecule PSMA-targeted PET radiotracer. CONDOR was a prospective study designed to determine the performance of 18
F-DCFPyL-PET/CT in patients with BCR and uninformative standard imaging. Read More
Patterns of Disease Detection Using [18F]DCFPyL PET/CT Imaging in Patients with Detectable PSA Post Prostatectomy Being Considered for Salvage Radiotherapy: A Prospective Trial - Beyond the Abstract
Positron emission tomography (PET) using a variety of tracers can reliably detect sites of prostate cancer before abnormalities can be appreciated using conventional imaging, particularly with respect to local recurrence and metastatic disease and 68
Ga labelled PSMA ([68
Ga]Ga-PSMA-11) tracer is the most widely reported.1 Read More
[18F]DCFPyL PET/CT in Detection and Localization of Recurrent Prostate Cancer Following Prostatectomy Including Low PSA 0.5 ng/mL - Beyond the Abstract
The aim of this retrospective multicenter analysis was to assess the performance of [18F]DCFPyL prostate-specific membrane antigen (PSMA) PET/CT in the detection and localization of recurrent prostate cancer following radical prostatectomy (RP). Although the use of PSMA PET/CT in biochemical failure post-prostatectomy has been validated by international literature as being superior to conventional imaging1,2
and having a significant impact on management,2-8 Read More