Fusion Guided Prostate Biopsy

Prostate cancer care relies, above all, on the accurate and early detection of cancer sites. Currently, biopsy (transrectal or transperineal approach) is the only means able to determine the presence of cancer and establish the corresponding prognosis, on the basis of the size and aggressiveness of tumours.

Worldwide, over 90% of prostate biopsies are still performed “blind”. That is, without the use of technology to find one’s bearings within the organ.

Conventional biopsy cancer detection rate is relatively low compared to MRI/US fusion biopsy.

60%

MRI/US Fusion Cancer Detection Rate

30%

Conventional Biopsy Cancer Detection Rate

For this reason:

  • In cases of negative results, the hypothesis of cancer cannot be ruled out.

  • In cases of low-positive results, suspicion of more aggressive cancer may remain.

“Conventional” Biopsy : Possible results

Random biopsy results

25% of cases

Biopsy misses the tumor

non significant prostate cancer detection with Trinity®

Fortuitous reaching of non significant cancer

random prostate biopsy results

Underestimation of tumor’s size

Delaying the diagnosis, under- or overestimating the aggressiveness of the disease and, ultimately, failing to provide the best possible care for the patient.

However, the evolution of medical imaging techniques (MRI) together with advances in fusion technologies (MRI-US) have changed the landscape where practices are concerned.

In technical terms, “targeted” biopsies are made possible by the fusion of ultrasound (US) images of the prostate with MRI scans or PET sequences, in real time during the procedures.

What is MRI-Ultrasound Fusion Biopsy?

UCLA experience with MRI/US Fusion technology:

The use of multiparametric MRI prior to the biopsy has considerably improved the sensitivity and specificity of diagnoses for prostate tumours.

These MRI sequences are interpreted by a specialist radiologist, with expertise in screening for and identifying the presence of potential cancer sites within the prostate. A PI-RADS score (from 1 to 5 – indicating the probability of clinically significant cancer) is then attributed by the specialist radiologist to each of the suspicious areas identified.

The MRI provides a good negative predictive value, such that a test performed by a specialist radiologist, concluding upon the absence of suspect areas, may constitute a sufficient reason to defer the biopsy1. Nonetheless, in conjunction with MRI, guided biopsy remains the only conclusive method of diagnosing prostate cancer.

Once interpreted, the MRI scans are sent to the urologist. Fused with the ultrasound (US) images during the procedure itself, MRI enables precision guidance during biopsies (+/- 2.3 mm) 2 directly within the areas to be sampled.

The new benchmark in the field – “targeted” fusion biopsies – now enables:

  • Pre-biopsy visualisation of potential cancer lesions

  • Precise targeting of biopsies performed

  • A reduction in the number of samples taken during a biopsy procedure

  • Faster, more accurate and more reliable diagnosis

  • Limitation of the risks of over-diagnosis and over-treatment of prostate cancer

  • Care tailored to the patient and their disease

  • Use of new treatments that give patients better quality of life (Active Surveillance/Focal Treatment)

Workflow during prostate fusion biopsy exam (20-25 minutes per patient)

MRI/US contour of the prostate

1. Radiologist defines suspicious lesion on the MRI

mri ultrasound fusion prostate biopsy image

2. MRI and 3D Ultrasound Image Fusion

Virtual prostate biopsy

3. Virtual Targeted Biopsy

Targeted Prostate Biopsy

4. Real Targeted Biopsy

Random prostate biopsy

5. Systematic Biopsy

3D prostate mapping Koelis

6. 3D Cartography

Example of MRI/US Image fusion using KOELIS technology 

prostate cancer magnetic resonance imaging mri Prostate Ultrasound image

MRI-TRU fusion guided prostate biopsy Step by step video 

Source: Nima Nassiri et al. Institute of Urology, Keck School of Medicine, University of Southern California. Video originally uploaded on Intbrazjurol

Need evidence about MRI fusion technology?

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Cognitive VS Software-Based Fusion

There are various methods of fusing MRI and ultrasound scans:

Cognitive Fusion Biopsy

This is based solely on the experience of the urologist, who superimposes the MRI scans onto the ultrasound images “from memory” and in real time. As the suspect areas detected during the MRI do not appear on the ultrasound images, precise targeting of the biopsies is not guaranteed.

Rigid or Elastic Software-Based Fusion

This consists of digitally superimposing the MRI scans onto the ultrasound images. Suspect areas detected by the MRI are thereby displayed on the ultrasound scanner, allowing the urologist to target the necessary biopsies.

Recent studies have proven that (Rigid or Elastic) software-based MRI-US image fusion systems are more effective than cognitive fusion:

Precision matters in MRI targeted biopsy CORNUD et al., Radiology. 2018 May; 287(2)3

MRI/TRUS Fusion biopsy using Koelis technologies

This study measures the precision in the placement of a biopsy needle in a MRI target through MRI/TRUS fusion guidance using KOELIS OBT Fusion™ technology compared to cognitive fusion.

Results: Cores obtained with the fusion technique achieved a higher precision than did cores obtained with the cognitive techniques 2.8 mm vs 7.1 mm. Fewer cancers were detected with the cognitive technique than with the fusion technique.

Other major publications: 

  • Comparative Effectiveness of Targeted Prostate Biopsy Using Magnetic Resonance Imaging Ultrasound Fusion Software and Visual Targeting: a Prospective Study – Lee DJ et al. J Urol – September 20164
  • Prostate Cancer Detection Rate with Koelis Fusion Biopsies versus Cognitive Biopsies: A Comparative Study. – Oderda et al. Uro Int.  June 20165
  • First round of targeted biopsies using magnetic resonance imaging/ultrasonography fusion compared with conventional transrectal ultrasonography-guided biopsies for the diagnosis of localised prostate cancer. Mozer et al. –BJU Int – January 2015 6

Rigid VS Elastic Fusion

The precise overlay (fusion) of MRI-ultrasound images is essential in order to guarantee that the potential cancer sites are targeted during a biopsy.

When superimposing these images, two factors must be taken into account:

The prostate is a supple and mobile organ – During a biopsy, the endorectal ultrasound probe and patient movements cause deformations of the organ.

The delay between the MRI and biopsy procedure – The prostate is an organ that changes over time (for example, enlargement).

In the case of “rigid” fusion, the MRI scans are simply superimposed onto the ultrasound images. Conversely, with “elastic” fusion, the MRI scans are superimposed then automatically adjusted to better correspond to the contours of the ultrasound images at time T.

As such, elastic fusion is the only method that enables the accurate display of the suspect areas previously identified by the MRI.

rigid elastic fusion prostate biopsy

Recent studies have proven that Elastic fusion are more effective than rigid fusion:

  • 3-Dimensional elastic registration system of prostate biopsy location by real-time 3-dimensional transrectal ultrasound guidance with magnetic resonance/transrectal ultrasound image fusion. – Ukimura et al. J Urol – March 20127
  • Precision of MRI/ultrasound-fusion biopsy in prostate cancer diagnosis: an ex vivo comparison of alternative biopsy techniques on prostate phantoms. – Westhoff Net al. World J Urol – July 20178

The Organ-Based Tracking Fusion™ Revolution

During the course of a biopsy, the prostate becomes deformed and displaces itself in relation to its initial position (pressure exerted by the probe, patient movements, etc).

Organ-Based Tracking Fusion™(OBT Fusion™) is a patented KOELIS innovation that works in tandem with elastic fusion technology.

Unlike other technologies that track the movement of the probe (robotic technology or electromagnetic sensors), OBT Fusion™ tracks the shifting prostate and automatically compensates for these movements therefore maximising the accuracy of the procedure.

This breakthrough was made possible thanks to a 3D endorectal probe and image processing software exclusive to KOELIS. KOELIS Trinity™Fusion Biopsy system is the only one in the world equipped with this technology.

For further information about OBT Fusion: Video coming soon…

The Advantages of MRI-US Fusion Biopsy

Software-based MRI-US fusion guided biopsy marks a turning point in prostate cancer care for a number of reasons.

Use of Magnetic Resonance Imaging (MRI)

Urologist In addition to a digital rectal exam and PSA test, MRI enables suspicions of cancer to be confirmed or eliminated. If the MRI is positive, the tumours can be located and measured.
Patient Non-invasive test and rapid results for the patient.

3D visualisation of the prostate

Urologist The 3D mapping of the prostate generated by the software by way of MRI-US fusion guarantees an accurate visualisation of the potential cancer sites.
Patient The 3D images make it easier for the patient to understand the disease.
3D prostate mapping

Three dimensional image of the prostate show the suspicious areas (orange) and the positive targeted biopsy cores (red)

Prostate map with cancer lesion in 3D

Three-dimesional transrectal US fused image shows the suspicious focus (yellow) that was targeted by two (red) targeted cores in complement to 12 random (green) systematic cores.

Targeted, precise and recorded biopsies

Urologist Targeted, guided and recorded biopsies guaranteeing that changes in tumours can be monitored over time. Also allows information to be shared with other specialists during multidisciplinary team meetings (MTMs).
Patient Certainty of benefitting from the latest technological advances + Confidence in the test performed + Guarantee of ongoing personalised monitoring.

Personalised prostate cancer care

Urologist Definition of a treatment protocol tailored to the patient’s needs and ability to monitor the progress of treatment over time.
Patient The results will enable effective, appropriate and personalised care – No risk of under- or over-treating prostate cancer!

 

For more information about treatments, visit: → Active surveillance

 

NEW Prostate Cancer Guidelines: MRI First

EAU Prostate Cancer Guidelines 2019

According to the latest directions, the early use of multiparametric magnetic resonance imaging (mpMRI) before a prostate biopsy is recommended in both biopsy naïve patients and in patients with a prior negative biopsy for the detection of prostate cancer.

EAU 2019 recommendations in biopsy naive patients

Perform mpMRI before prostate biopsy

  • When mpMRI is positive (PI-RADS ≥ 3), combine targeted & systematic biopsy
  • When mpMRI is negative (PI-RADS ≤ 2) and clinical suspicion of prostate cancer is low, omit biopsy based on shared decision making with the patient.

EAU 2019 recommandations in patients with prior negative biopsy

Perform mpMRI before prostate biopsy

  • When mpMRI is positive (PI-RADS ≥ 3), perform targeted biopsy only
  • When mpMRI is negative (PI-RADS ≤ 2), and clinical suspicion of prostate cancer is high, perform systematic biopsy based on shared decision making with the patient

More information about EAU 2019 Prostate Cancer Guidelines

French Urology Association Guidelines

Using magnetic resonance imaging (MRI) as an initial test for suspected prostate cancer patients is now recommended by the French Urology Association.

Biopsy naive patients should have systematic biopsies when their MRI is negative, while the ones whose MRI is positive (PIRADS>=3) should undergo systematic biopsies combined with targeted biopsies. Regarding patients with prior biopsy, the performance of a (mpmri) multiparametrical MRI before another biopsy session is recommended.

 

 

These guidelines are based on the previous multicenter PRECISION and MRI First studies results, where KOELIS has provided its precise fusion technology.

NICE New Prostate Cancer Guidelines

The National Institute for Health and Care Excellence (NICE) highly recommends the use of mpMRI scanning as a first-line test for patients with suspected clinically localised prostate cancer. Multiparametric MRI scan before biopsy is also recommended for patients with clinically significant prostate cancer since it helps to locate the cancer and to target it directly.

More information about NICE Prostate Cancer Guidelines

KOELIS™ technology for fusion biopsy

For over a decade KOELIS, The Prostate Care Company, has assisted urologists and radiologists from around the world in their routine clinical practice providing the latest technology for personalized prostate cancer.

We propose precise real-time 3D transrectal ultrasound (TRUS) and 3D transperineal ultrasound (TPUS) fusion-guided prostate biopsy against conventional and random systematic biopsy to increase sampling quality with KOELIS Trinity™. In a simple process and device, KOELIS Trinity™ cartographer is a powerful diagnostic tool to plan, implement, review and control a personalized care solution. It creates a detailed and personalized map of the patient’s prostate showing exact core distribution since our image-based cartographer is equipped with the Organ-Based Tracking™ technology. Without changing the usual clinical practices, this technique leads to increased control from biopsy localizations specifically for each patient and consequently, to higher detection rate and stronger basis for further prostate cancer management.

“Health innovation as a passion”

In KOELIS, we innovate every day in collaboration with world-renowned universities and hospitals to offer physicians new advancements in imaging and a greater field of view in order to bring personalized answers to every patient, in the respect of their quality of life.

Do you have questions about our precision fusion technology? Find the common inquiries or contact us !

To locate a clinic equipped with our solutions: Discover our interactive map.

Last updated on May 10th 2019

  1. MRI-Targeted or Standard Biopsy for Prostate-Cancer Diagnosis – Veeru Kasivisvanathan et al. – New England Journal of Medicine – March 2018
  2. Precision Matters in MR Imaging-targeted Prostate Biopsies: Evidence from a Prospective Study of Cognitive and Elastic Fusion Registration Transrectal Biopsies. Cornud et al. – Radiology –  May 2018
  3. Precision Matters in MR Imaging–targeted Prostate Biopsies: Evidence from a Prospective Study of Cognitive and Elastic Fusion Registration Transrectal Biopsies- Cornud et al. Radiology – May 2018 
  4.  Comparative Effectiveness of Targeted Prostate Biopsy Using Magnetic Resonance Imaging Ultrasound Fusion Software and Visual Targeting: a Prospective Study – Lee DJ et al. J Urol – September 2016
  5. Prostate Cancer Detection Rate with Koelis Fusion Biopsies versus Cognitive Biopsies: A Comparative Study. – Oderda et al. Uro Int.  June 2016
  6. First round of targeted biopsies using magnetic resonance imaging/ultrasonography fusion compared with conventional transrectal ultrasonography-guided biopsies for the diagnosis of localised prostate cancer. Mozer et al. –BJU Int – January 2015
  7. 3-Dimensional elastic registration system of prostate biopsy location by real-time 3-dimensional transrectal ultrasound guidance with magnetic resonance/transrectal ultrasound image fusion. – Ukimura et al. J Urol – March 2012 
  8. Precision of MRI/ultrasound-fusion biopsy in prostate cancer diagnosis: an ex vivo comparison of alternative biopsy techniques on prostate phantoms. – Westhoff Net al. World J Urol – July 2017