
Introducing aPROMISE
aPROMISE, is a medical device software created by EXINI to standardize and quantify the interpretation and reporting of PET/CT imaging1,2 (see below).
The reporting is inspired by the PROMISE criteria (PROstate cancer Molecular Imaging Standardized Evaluation)3, developed by a group of leading prostate cancer clinics and anticipated to increase the value of PSMA PET/CT examinations by making interpretation more quantitative and consistent.
The software automatically analyzes the CT image to segment anatomical regions, including liver and aorta. Subsequently, the PET image is analyzed to detect target hotspots, regions of locally elevated intensities indicative suspicious metastasis. Each target lesion is labeled with location and quantified in terms of both intensity and volume. The standardized aPROMISE report provides referring physicians with a comprehensive understanding of disease status and makes monitoring of patients’ disease management course more consistent.
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 MDD 93/42 EEC, and is available for clinical use in Sweden and Ireland.
- 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.
- 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.
- Prostate Cancer Molecular Imaging Standardized Evaluation (PROMISE): Proposed miTNM Classification for the Interpretation of PSMA-Ligand PET/CT. Eiber M, Herrmann K, Calais J, Hadaschik B, Giesel FL, Hartenbach M, Hope T, Reiter R, Maurer T, Weber WA, Fendler WP. J Nucl Med. 2018 Mar;59(3):469-478.
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 Team Concept
Studies that are uploaded to aPROMISE is automatically added to the patient list. The patient list is shared with the team thanks to the aPROMISE team concept.

aPROMISE Viewer
The aPROMISE viewer is a multi modal viewer with PET, CT, Fusion and MIP images. The available study information is shown in the control panel to the left.

aPROMISE Segmentation
The software automatically analyzes the CT image to segment anatomical regions, including liver and aorta.

aPROMISE Lesion Selection and Quantification
Lesion selection is a tool that enables users to save volumes with high uptake for reporting and quantitative analysis. Each selected lesion is shown in the left control panel.
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 agreement of calls between the readers if a subject is positive or negative for pelvic lymph node metastasis was observed at 0.680 (95% CI 0.608-0.751). 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 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. Information made available on or through aPROMISE 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). Överensstämmelsen mellan granskarna i fastställandet huruvida ett subjekt är positivt eller negativt för lymfkörtelmetastaser i bäckenet observerades till 0,680 (95 % KI 0,608–0,751). 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 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. Information som tillhandahålls i eller via aPROMISE ska inte användas som enda grund för beslut om diagnos eller val av behandling av ett sjukdomseller hälsotillstånd.