Trial of Augmented Reality GuidEd Transperineal prostate biopsies
Research type
Research Study
Full title
TARGET: The first experience of Augmented Reality GuidEd Transperineal targeted prostate biopsies
IRAS ID
282488
Contact name
C BLICK
Contact email
Sponsor organisation
Royal Berkshire Hospital NHS Foundation Trust
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
Prostate cancer is the most common cancer in UK men, with on average 47,740 new cases diagnosed annually and is increasing in incidence year on year.
The diagnosis of prostate cancer is made after a prostate biopsy and current guidelines support pre-biopsy magnetic resonance imaging (MRI) of the prostate in patients with suspected prostate cancer (1). Images from the MRI are reported by a radiologist who will identify suspicious areas for prostate cancer within the prostate to facilitate more accurate biopsies. Scans are given a PIRAD score from 1-5, those with a score of 4 or 5 correspond to suspicious areas in the prostate and are associated with an 42.3% and 82.4% chance of harbouring underling prostate cancer respectively. (2) Current methods used to target these regions of interest with a biopsy needle include standard systematic biopsies, cognitive fusion biopsies and MRI/Ultrasound fusion biopsies. This can be via the transrectal route (with a higher risk of infection and severe sepsis due to cross contamination by the rectal flora) or the transperineal route which harbours fewer infection risks but often requires both a general anaesthetic and theatre space utilisation.
Current biopsy techniques are associated with suboptimal diagnostic accuracy, with transrectal prostate biopsies missing as much as 1 in 2 significant prostate cancers. (3) This has meant that patients often require additional sets of biopsies, increasing the risk of complications such as pain, bleeding, infection (which may result in sepsis) and difficulty passing urine. There are also significant financial costs in terms of clinic, theatre and pathology utilisation time from these additional procedures.
Importantly to patient care, such delays may add to the psychological stress for patients, as they are left for a longer period of time without a definitive diagnosis or management plan.The commonly used cognitive fusion biopsy technique involves a clinician using MRI images as a visual mental road map to target the subsequent biopsies. This method is associated with false negative rates of up to 35%. MRI and Ultrasound fusion techniques are lengthy procedures during which, MRI images are calibrated to a transrectal ultrasound probe prior to biopsy. Anecdotally this is a time-consuming process to both set up and learn how to use.
The Hololens device and Apoqlar software – Virtual Surgery Intelligence (VSI). VSI runs on the mixed reality glasses HoloLens device. The user is able to visualise virtual 3D Holograms of important patient information, prepared by artificial intelligence (AI), such as
lab results, MRI/CT scans, surgical reports etc, in real space in front of them. With voice commands
these can easily be toggled to allow the wearer full control. The surgeon will be able to slice DICOM data in 3D . Using artificial intelligence, the 3D visualization
is superimposed one-to-one on the patient‘ s body, giving the surgeon a perfect understanding and orientation of the anatomy aiding accurate targeted prostate biopsy.We propose to test a new approach to targeted biopsies using a novel augmented reality platform, utilising software provided by Apoqlar, and the Hololens device (Microsoft). For the first time a surgeon will see the MRI image of the prostate, through the hololens device and use this technology to guide the needle in real time directly towards the region of suspicion. This technique has the potential to increase diagnostic accuracy, increase efficiency and could potentially be performed without general anaesthetic improving capacity and reducing delays in the diagnostic pathway. Improving diagnostic accuracy will reduce the number of unnecessary prostate biopsies and costs associated with this technique.
REC name
West Midlands - Solihull Research Ethics Committee
REC reference
20/WM/0249
Date of REC Opinion
22 Sep 2020
REC opinion
Favourable Opinion