PYLARIFY AI™ enables accurate, efficient, and reproducible quantification of PYLARIFY® PET/CT scans1,2


PYLARIFY AI™ is the only FDA-cleared medical device to offer standardized quantitative and accurate reporting of PSMA PET/CT images, including those achieved using PYLARIFY® PET/CT.1 Standardized reporting of PSMA assessments can improve the management of prostate cancer patients, including the accurate quantification of disease burden with increased reproducibility on a patient level.1,2

Reproducible and Quantitative Disease-burden Indices2,3

  • Improved interreader reproducibility in staging (κ >0.80) and quantification (ICC: 0.99) of prostate cancer patients2,3
  • Quantitative PSMA scan index (PSI) was associated with PSA and Gleason Score2

Accurate Lesion Quantification3

  • High segmentation and detection accuracy (>90%) for PSMA lesions in regional and distant lymph nodes3

Clinical Utility2

  • A quantitative PSMA score/index can help stratify patients for available treatment options2
  • A quantitative PSMA score/index can accurately demonstrate disease progression and response2

High Efficiency2

  • Significant efficiency in creating quantitative structure reporting, averaging 3-5 minutes for a comprehensive, quantitative report2

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Without AI, interpreting PET/CT scans can be slow, tedious, and inconsistent3-5

QUANTIFICATION3-5
  • Quantitative assessment of lesions via PET/CT is variable due to manual process and limited tools, which reduces the clinical utility of the procedure3,4
  • ~90% of metastatic patients have bone metastases, which are particularly challenging to assess5
REPRODUCIBILITY3
  • Inter-institutional and interreader assessment is variable due to manual delineation and/or threshold-based segmentation3
EFFICIENCY AND ACCURACY3
  • Reading high-burden cases can lead to fatigue and increase the risk of interpretation errors3

What is PYLARIFY AI™?3


PYLARIFY AI™ is a deep-learning-enabled application that standardizes comprehensive quantitative reporting through3:

What does PYLARIFY AI™ report on?1,3

  1. PYLARIFY AI™ automatically analyzes the CT image to segment anatomical regions, including the liver and the thoracic part of the aorta, as reference organs
  2. Subsequently, PYLARIFY AI™ analyzes the PET image to detect target hotspots, regions (ROIs) of locally elevated PSMA tracer intensities indicative of suspicious tumor tissue and metastasis
  3. ROIs are marked by selecting from predefined hotspots or by manual drawing
  4. The selected lesions are labeled with type and location, and quantified in terms of standard uptake values (SUVs) for tracer uptake intensities and their respective volumes
  5. When used by radiology professionals, the standardized PYLARIFY AI™ report provides consistent and quantitative assessments of PSMA PET/CT images

Introducing the PSMA Scan Index (PSI)™2

  • A unique quantitative assessment based on the unique physiological uptake of PSMA and inspired by recommended guidelines for PSMA assessment
PSMA Scan Index PSMA Scan Index
Sample report. Not an actual patient.

How does PYLARIFY AI™ work?3


Deep-learning-enabled segmentation of anatomical context in low-dose CT of PSMA PET/CT

How PYLARIFY® AI™ works How PYLARIFY® AI™ works
Sample report. Not an actual patient.

DESIGNED TO COMPLEMENT THE CLINICAL WORKFLOW


PYLARIFY AI™ deployment can be facilitated both as a secure web cloud application and as a local server application to secure private patient data.

Once deployed, the adaptive application can be integrated to the institution's image acquisition platforms or to the Picture Archiving and Communication Systems (PACS). The report generated from PYLARIFY AI™ is available in DICOM and JPG format and can be attached in the existing clinical impression for the physician’s review.

Seamless integration into existing clinical workflow (eg, linking to PACS) delivers a unique combination of clinical utility in a workflow-friendly package.

CT=computed tomography; PET=positron emission tomography; PSMA=prostate-specific membrane antigen; ROI=region of interest.

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INDICATION

PYLARIFY® (piflufolastat F 18) Injection is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

  • with suspected metastasis who are candidates for initial definitive therapy.
  • with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

References

  1. FDA approval letter for aPROMISE. Food and Drug Administration. July 27, 2021.
  2. Nickols N, Anand A, Johnsson K, et al. aPROMISE: a novel automated-PROMISE platform to standardize evaluation of tumor burden in 18F-DCFPyL (PSMA) images of veterans with prostate cancer [published online ahead of print, 2021 May 28]. J Nucl Med. 2021. doi:10.2967/jnumed.120.261863
  3. Johnsson K, Brynolfsson J, Sahlstedt H, et al. Analytical performance of aPROMISE: automated anatomic contextualization, detection, and quantification of [18F]DCFPyL (PSMA) imaging for standardized reporting [published online ahead of print, 2021 Aug 31]. Eur J Nucl Med Mol Imaging. 2021. doi:10.1007/s00259-021-05497-8
  4. Alipour R, Azad A, Hofman MS. Guiding management of therapy in prostate cancer: time to switch from conventional imaging to PSMA PET? Ther Adv Med Oncol. 2019;11:1-14. doi:10.1177/1758835919876828
  5. Bubendorf L, Schöpfer A, Wagner U, et al. Metastatic patterns of prostate cancer: an autopsy study of 1,589 patients. Hum Pathol. 2000;31(5):578-583. doi:10.1053/hp.2000.6698