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BiopSee®

Advanced image-guided prostate fusion biopsy system

BiopSee

BiopSee® fuses the mp-MRI images with ultrasound images in real-time, allowing highly accurate placement of the biopsy needles in the prostate, to target the tumour with exceptional precision. 3D ultrasound image acquisition, rigid/elastic fusion capabilities together with comprehensive documentation, reporting software and interfaces to practically all therapy alternatives (cryotherapy, brachytherapy, HIFU, RF, photodynamic or any other treatment method) deliver an exceptional platform supporting the doctors in an optimal way.

Fusion Biopsy

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Prostate MRI and fusion biopsy play an important role in the screening, evaluation, diagnosis, targeted biopsy, surveillance and focal therapy of the prostate cancer patient.

MRI/US fusion superimposes diagnostic MRI images over a real-time ultrasound. This allows targeting of suspicious lesions seen on MRI to be biopsied under real time ultrasound. The goal is to combine the high soft tissue resolution of the MR image with the real-time visualization of TRUS.

The doctor guides the biopsy needle to suspicious areas after co-registering MRI and US image.

According to clinical studies the detection rate of prostate cancer with a random TRUS biopsy is around 33% and by using the BiopSee® Solution: U/S-MRI image fusion & navigated biopsy the general success rate doubles to 58%-70% and for targeted on mp-MRI-suspicious locations reaches a high of 86%-100%

Why Fusion Biopsy?

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  • Prostate cancer can be hard to detect
  • The traditional digital rectal exam isn’t a very effective screening tool
  • The prostate specific antigen (PSA) blood test, since 1994 a companion to the digital rectal exam for screening older men, measures levels of a protein that often go up when prostate cancer is present
  • Drawbacks of random biopsy:
    • Numerous needles (about 12 to 24) into different prostate areas, guided by ultrasound.
    • The ultrasound images help placing the needles properly, but the pictures aren’t distinct enough to distinguish cancerous from normal prostate tissue
  • An MRI scan has a higher resolution than ultrasound images and reveals more details in soft tissue, such as the prostate gland
  • It is not yet scientifically approved that prostate cancer can be diagnosed from an MRI image, but it certainly can be used to identify suspicious areas

Prostate Biopsy Facts

The challenge: systematic TRUS biopsies show low CA-detection

  • TRUS random biopsy (12 cores) success rate: ~33%
  • TRUS saturation biopsy (30 cores) success rate: ~40%

BiopSee® Solution: U/S-MRI image fusion & navigated biopsy

  • General success rate 58%-70%
  • Targeted on mp-MRI-suspicious locations 86%-100%

Transrectal Biopsy

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Ultrasound (US)-guided biopsy is now the standard of care. A transrectal approach is used for most prostate biopsies, although some urologists prefer a transperineal approach. Usually the procedure is performed under local anesthetic. A needle is attached to a biopsy gun and mounted on a ultrasound probe and inserted through the rectal wall into the prostate to acquire biopsy cores under the guidance of US images

12 biopsy cores are ‘randomly but systematically’ acquired from different zones of the prostate without a patient-specific plan (i.e. without regard to specific location of the abnormalities)

  • Limitations of systematic biopsy technique
    • False-Negative Biopsy (under sampling)
    • Incorrect Risk Stratification (under sampling)
    • Detection of Clinically Insignificant Disease (over sampling)
    • Necessity of Repeat Biopsy (reduction of sampling error by increasing sampling)

Fusion Transrectal Biopsy with BiopSee®

Using BiopSee® the transrectal biopsy is not anymore blind, since the suspicious lesions noted by the radiologist in the MRI of the prostate, can be overlaid with the live ultrasound image to target the needle in the suspicious area of the prostate.

Transperineal Biopsy

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Transperineal biopsy is a biopsy procedure in which a sample of tissue is removed from the prostate for examination under a microscope. The sample is removed with a thin needle that is inserted through the skin of the perineum (between the scrotum and anus) and into the prostate. Imaging is obtained by an ultrasound probe passed into the rectum. This approach has the potential for improved sampling, particularly in men who have had a previous negative Transrectal (TRUS) biopsy.

The transperineal biopsy has the additional potential advantage of a much lower risk of infection, as the skin of the perineum can be easily disinfected by routine surgical preparation immediately prior to the procedure, whilst with TRUS biopsy there is a significant risk of infection from bacteria entering the bloodstream because the biopsy needle passes through the rectal wall.  In addition, the transperineal path enables approaching also the ventral prostate areas, typically omitted in the usual transrectal TRUS methodology.

BiopSee® Solution: U/S-MRI image fusion & navigated TP biopsy

Clinical Results: Cancer Detection with BiopSee®

  • MRI suspicious areas: 86-100%
  • MRI non-suspicious areas: 12%
  • MRI does not detects all CA (false negatives)

CA detection probability per core

  • 30% CA in MRI-targeted cores
  • 8% CA in random systematic cores
    • MRI indicates more CA (false positives)
    • Navigated cores are not enough, additional systematic sampling needed

Target accuracy (stereotactically): 1.7 mm

Abdominal Biopsy

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Abdominal (percutaneous) biopsy is a biopsy in which a needle is inserted and a tissue sample removed through the skin. During a kidney (renal) biopsy the doctor removes a small piece of kidney tissue to examine under a microscope for signs of damage or disease. An imaging device helps the doctor guide the needle into the kidney to remove tissue.

How Can BiopSee® Help You?

BiopSee® is assisting the procedure by superimposing other image modalities like CT or MRI with higher medical imaging importance. This way the target has a higher chance to be reached and to be further examined. In addition for areas which are hard to be reached using normal needle guides attached on the ultrasound probe, BiopSee® uses high precision tracked needles which can be easily navigated without the use of a fixed needle guide which restricts the movements.

Clinical Value Benefits with BiopSee®

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  • Intuitive, simple, fast learning, precise workflow
  • Improve the diagnostic accuracy with MRI/PET/US fused biopsies
  • Eliminate the risk of missing pathologies on systematic biopsies
  • Accurate navigation to suspicious areas
  • Monitor and follow-up the patients
  • Therapy support

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