Prostate Intelligence
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Prostate IntelligenceTM is a radiological analysis software indicated for use in the assessment of MRI images of males aged 21 or over with the suspicion of prostate cancer.
Use of the software has the following expected clinical benefits:
- Identify patients not at risk of csPCa (clinically significant prostate cancer) through provision of a risk score that can be considered as part of the decision to biopsy.
- Find more significant cancer, by highlighting high-risk lesions that radiologists might miss, enabling more accurate targeting.
- Speed up the process, by facilitating assessment and segmentation tasks through provision of candidate prostate and lesion segmentations.
- Identify estimated volume of prostate and lesions.
It also has additional wider benefits such as:
- Use software for training purposes – i.e., as an adjunct for teaching non-experienced radiologists how to use and report.
- Allow more resource for processing scans hence reducing the workload in the clinical setting (i.e., no need to calculate tumour volume or fill a structured report manually).1
PI Output
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- T2 Axial
- ADC
- Multiple B-value DWI
- DCE (contrast) - Optional
Segmentation and Images
- The following segmentations are available:
- Prostate
- Seminal vesicles (SV)
- Lesions
- Combined prostate, SV and lesion segmentations
Note that where no lesions are found, no lesion segmentations are output.
- The following image types are available:
- Imported T2 axial and ADC
- High B-value DWI generated by PI
- Imported T2 axial, with superimposed segmentations and lesion overlays
- Post-processed DCE (contrast) image highlighting areas of rapid contrast uptake
Reports
- The template report incorporates the patient history, if provided, and the following results of analysis:
- Highest AI-Likert score: a score indicative of the level of risk that the patient may have clinically significant prostate cancer, as a continuous value between 1.0 and 5.0.
- A list of candidate regions of interest, each with a Lesion AI-Likert score between 1.0 and 5.0 indicative of the risk that each such candidate region of interest corresponds to an area of clinically significant prostate cancer.
- Diagrams illustrating the prostate segmentation and each candidate region of interest.
EU risk class and CE marking
Prostate Intelligence has CE marking (CE0459) and risk class IIb
Reimbursement status
Not reimbursed
Contraindications
- There are currently no reported residual risks, contraindications, and undesirable side-effects
- The software is not intended for use:
- for staging
- to control equipment for prostate biopsy or treatment, for example to automatically drive robotic or energy delivering devices (e.g. radiotherapy machine).
- to control or monitor any other device.
- The software must not be used with patients:
- who received a prostate biopsy within 6 weeks before the MRI examination
- with prior prostate or urethral treatment or surgery
- whose MRI scan quality is severely impaired, for example by patient motion, breathing, peristaltic motion, rectal gas, or metallic implants such as hip prostheses
- where a radiologist considers that the MRI examination is not of diagnostic quality
- with MRI examinations that do not follow PI-RADS®v2.1 scanning protocols
- whose MRI images have been captured using an endo-rectal coil.
Target Population
Prostate IntelligenceTM is a radiological analysis software indicated for use in the assessment of MRI images of biological males aged 21 or over with the suspicion of prostate cancer.
Limitations
- None described
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