A Pilot Study of Dynamic 18F-DCFPyL PET/CT Imaging of Prostate Adenocarcinoma in High-Risk Primary Prostate Cancer Patients - Beyond the Abstract
When is the optimal imaging time for 18F-DCFPyL? The package insert recommends imaging 60 minutes after radiotracer injection and furthermore, discourages imaging beyond 90 minutes, but validated evidence for this is lacking. What has been published is that imaging obtained 120 minutes after 18F-DCFPyL injection depicts more metastatic lesions than imaging at 60 minutes.1,2
Additionally, lesions at 120 minutes have better conspicuity and in one study, 9% of men were upstaged resulting in management changes due to findings on delayed images.3
Our dynamic data suggests later imaging results in higher tumor uptake. Read More
Lantheus Announces Addition of PSMA PET Imaging Agent to the National Comprehensive Cancer Network® (NCCN) Guidelines for Prostate Cancer
Lantheus’ product, PYLARIFY (piflufolastat F18) injection, is the first and only commercially available and FDA-approved PSMA-targeted PET imaging agent for prostate cancer
San Francisco, CA (UroToday.com) -- Lantheus Holdings, Inc. (the “Company”), 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, Read More
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