Introducing aPROMISE

aPROMISE is a medical device software developed by EXINI Diagnostics AB. aPROMISE is a PACS platform that offers quantitative analysis and standardized reporting of PSMA PET/CT image assessments. The software has a solution for automated body segmentation and marking, quantifying and reporting of regions of interest (ROIs) considered as suspicious lesions 1,2. The automated segmentation of reference organs and detection of ROIs with high local intensity uptake, so called hotspots, provide enhanced consistency in quantitative analysis and intend to increase efficiency of PSMA PET/CT image assessments.

In prostate cancer, PET tracers targeting the Prostate-Specific Membrane Antigen (PSMA) have demonstrated high diagnostic accuracy for the detection of both regional and distant metastatic prostate cancer. The higher sensitivity and specificity of the PSMA PET in detecting metastatic prostate cancer, may have strong implications in management of patients.

The aPROMISE software automatically analyzes the CT image to segment anatomical regions, including the liver and the thoracic part of the aorta as reference organs. Subsequently, the PET image is analyzed to detect target hotspots, regions of locally elevated PSMA tracer intensities indicative of suspicious tumor tissue and metastasis. ROIs are marked by selecting from predefined hotspots or by manually drawing and are then labeled with type and location and quantified in terms of standard uptake values (SUVs) for tracer uptake intensities and their respective volumes. The standardized aPROMISE report provides consistent and quantitative assessments of PSMA PET/CT.

As of December 2020, aPROMISE is provided as a secure and compliant web application readily available from a web browser by logging in to apromise.psmaix.com. In Europe, the device is CE-marked according to the MDR 2017/745, and is available for clinical use in Sweden and Ireland.

  1. Deep Learning-Enabled Comprehensive Detection and Quantification of 18FDCFPyL (PyL-PSMA) PET/CT. Brynolfsson J, Johnsson K, Sahlstedt H, Richter J, et al, OP-548, 1006: Cutting Edge Science Track – TROP Session: AI -Radiomics and Modelling, EANM 2020.
  2. miPSMA Index: Comprehensive and Automated Quantification of 18F-DCFPyL (PyL-PSMA) PET/CT for Prostate Cancer Staging. Johnsson K, Sahlstedt H, Brynolfsson J, et al. J Nucl Med. 2020;61(1):1435.

GDPR

When you use aPROMISE to process patient information related to a patient who is a resident of the EU, you
are responsible for ensuring that your organization complies with GDPR. In terms of GDPR you, as the user of
aPROMISE, are the data controller and EXINI, as the service provider, is the data processor. In advance of
processing data with aPROMISE, be sure that you have explicit consent from the patient whose data you are
capturing. When data is sent to aPROMISE, it is stored in a secure manner, and is encrypted in transit and at
rest.

Our Commitment

EXINI (‘we’ or ‘us’ or ‘our’) are committed and dedicated to ensuring the security and protection of the
personal information that we process, and to provide a robust, continuous and consistent approach to data
protection. Our objectives for GDPR and HIPAA compliance include the development and implementation of
data protection roles, policies, procedures, controls and measures to ensure continuous safeguarding of the
personal information under our remit.

How we are implementing GDPR and HIPAA

  • Policies & Procedures – Data protection policies and procedures to meet the requirements and
    standards of the GDPR and any relevant data protection laws, including HIPAA, are in place
  • Data Retention & Erasure – we have retention policies and are applying the privacy by design
    principle, meaning we store only data that is needed for the current task and only store it for as long
    as needed
  • Data Breaches – as a medical device manufacturer we have breach procedures in place that ensure
    safeguards and measures to identify, assess, investigate and report any personal data breach at the
    earliest possible time
  • International Data Transfers & Third-Party Disclosures – when EXINI stores or transfers personal
    information outside the EU, we have robust procedures and safeguarding measures in place to secure,
    encrypt and maintain the integrity of the data
  • Processor Agreements – when we use a third-party to process personal information on your behalf,
    we have data processor agreements and/or business associate agreements in place

aPROMISE

A software as a medical device manufactured by EXINI Diagnostics.

Performance Characteristics

In a prospectively planned independent analysis, aPROMISE demonstrated a high reproducibility between three nuclear medicine readers of quantitative SUVmax assessments with ICC 0.99 (95%CI 0.99 – 0.99). The percentage of the manually identified PSMA positive lesions that were automatically detected by aPROMISE: pelvic lymph nodes – 91.5%; all lymph nodes – 90.6%; and bones 86.7%.

Safety

aPROMISE-v.1.2 is only applicable for PSMA targeted PET/CT imaging and does not provide or substitute for medical services or advice. You are solely responsible for all decisions and actions resulting from your use of aPROMISE-v.1.2. Information made available on or through aPROMISE-v.1.2 should not be the sole information for making medical decisions or to diagnose or treat a medical or health condition.

Prestandaegenskaper

I en prospektivt planerad oberoende analys utförd av tre granskare verksamma inom nukleärmedicin uppvisade aPROMISE en hög reproducerbarhet för kvantitativa bedömningar av SUVmax, med korrelationskoefficienten 0,99 (95 % KI 0,99–0,99). Procentandelen av de manuellt identifierade PSMA-positiva lesioner som detekterades automatiskt med aPROMISE: lymfkörtlar i bäckenet – 91,5 %, alla lymfkörtlar – 90,6 %, benvävnad – 86,7 %.

Säkerhet

aPROMISE-v.1.2 är endast tillämpligt för PSMA PET/CT bilder och tillhandahåller inte och ersätter heller inte sjukvård eller medicinsk rådgivning. Du tar fullt ansvar för alla beslut och åtgärder som är ett resultat av din användning av aPROMISE-v.1.2. Information som tillhandahålls i eller via aPROMISE-v.1.2 ska inte användas som enda grund för beslut om diagnos eller val av behandling av ett sjukdomseller hälsotillstånd.

Trademark

EXINI® is a Registered Trademark.

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