A Novel 3D Navigation Technology for Improved TRUS Prostate Biopsy (NaSBxP01)
Recruitment status was: Recruiting
Prostate biopsy is a procedure in which small samples are removed from a man's prostate gland to be later tested for the presence of cancer. It is typically performed when the scores from a PSA blood test rise to a level that is associated with the possible presence of prostate cancer.
The most common method for performing a prostate biopsy procedure is the ultrasound guided transrectal procedure. The information obtained from the standard prostate biopsy is deficient and even misleading. Cancers can be missed on initial and even in repeated biopsy. Moreover, the detection of a tumor cannot predict accurately the tumor size and location1. It was proven that the exact location of the obtained cores, even in an initial biopsy, can influence the cancer detection rate2.
An imaging tool that will enable a three-dimensional navigation in the prostate volume and selecting biopsy locations in view of previous core taken will allow building a "tumor map" '(i.e. detecting tumor size and location). By mapping the prostate cancer an adequate treatment can be chosen while avoiding over or insufficient treatment.
However, to be able to produce an accurate mapping of the malignant tissue, a complementary optimized pathology method should be also implement in addition to the navigation system, it has been shown that a pre-embedding procedure that keeps the specimen orientation, unfolding, unity, and location along the needle notch improves the histological yield and hence the cancer detection rate3.
The NaviGo™ Workstation (hereafter the NaviGo™ Workstation or the NaviGo™ System) allows physicians to see the prostate gland together with the biopsy sites in a three dimensional (3D) view, modeled from two dimensional (2D) images. The NaviGo™ Workstation was designed as an adjunct to standard of care procedures, to work with standard rectal ultrasound probes, and to be incorporated side by side with the techniques currently employed. No change to the current employed procedures and techniques is required or suggested. In complementary to the Navigo system a system for semi-automatic download of prostate biopsy cores which keeps the orientation, unfolding and unity of the sample was developed to increase the pathology utility.
The study objective is to evaluate the contribution of the Navigo™ system, an aiding navigation tool for TRUS prostate biopsy, to an increase in the prostate cancer detection ability.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||A 3D Navigation Technology for Improved TRUS Prostate Biopsy|
- increased prostate cancer detection rate [ Time Frame: 30 days ] [ Designated as safety issue: No ]prostate cancer detection rate would be compared to that of a retrospetive cohort of patients who underwent prostate biopsy without the Navigo device.
|Study Start Date:||September 2011|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
Experimental: prostate biopsy using the Navigo system.
Evaluate the contribution of the Navigo™ system, an aiding navigation tool for TRUS prostate biopsy, to increase the prostate cancer detection ability.
Device: Navigo system
The NaviGo workstation is used as an adjunct to the ultrasound imaging and biopsy procedures of the prostate gland. When operated in conjunction with the standard equipment in a TRUS guided prostate biopsy procedure, the NaviGo™ software may be used for the following:
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01480375
|Bnai Zion medical center|
|Haifa, Israel, 31048|
|Principal Investigator:||Ofer Nativ, Prof.||Bnai Zion Medical Center|