TRACE4OC provides the woman's level of risk (very low risk or medium-high risk) of being affected with ovarian cancer at the date of the TRACE4OC-processed USI investigation of an adnexal mass, combined with the serum level test for Cancer Antigen 125 (CA-125), performed no earlier than and no later than one month from the USI study, and with the current woman’s menopausal state (premenopausal or post menopause).
Product specifications Information source: Vendor
Last updated: Nov. 18, 2021
General
Product name TRACE4OC
Company DeepTrace Technologies Srl
Subspeciality Abdomen
Modality Ultrasound
Disease targeted Ovarian cancer
Key-features Classification of risk of having ovarian cancer
Suggested use During: report suggestion
After: diagnosis verification
Data characteristics
Population Women at risk of ovarian cancer on the recommendation of gynecology specialists
Input Transvaginal US, 2D, single slice, ovarian mass, CA-125
Input format DICOM
Output Classification of medium-high risk vs very low risk, automated report
Output format PDF
Technology
Integration Stand-alone third party application
Deployment Locally on dedicated hardware
Trigger for analysis On demand, triggered by a user through e.g. a button click, image upload, etc.
Processing time 3 - 10 seconds
Certification
CE
Certified, Class I , MDD
FDA
No or not yet
Market presence
On market since 05-2021
Distribution channels
Countries present (clinical, non-research use) 1
Paying clinical customers (institutes) 1
Research/test users (institutes) 1
Pricing
Pricing model Subscription
Based on Number of users, Number of installations
Evidence
Peer reviewed papers on performance

  • A decision support system based on radiomics and machine learning to predict the risk of malignancy of ovarian masses from transvaginal ultrasonography and serum CA-125 (read)

Non-peer reviewed papers on performance
Other relevant papers