A Novel 3D Navigation Technology for Improved TRUS Prostate Biopsy (NaSBxP01)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01480375
Recruitment Status : Unknown
Verified January 2013 by UC Care, Ltd..
Recruitment status was:  Recruiting
First Posted : November 28, 2011
Last Update Posted : January 16, 2013
Information provided by (Responsible Party):
UC Care, Ltd.

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Device: Navigo system Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A 3D Navigation Technology for Improved TRUS Prostate Biopsy
Study Start Date : September 2011
Estimated Primary Completion Date : September 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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:

  • To assist the physician by transfer and display of ultrasound images on the workstation screen;
  • Build display and manipulate a 3D model of the prostate on screen;
  • Archiving the ultrasound images and the 3D model;
  • Providing data management solutions;
  • Tracking, displaying and recording of the biopsy needle trajectory location in real time.

Primary Outcome Measures :
  1. increased prostate cancer detection rate [ Time Frame: 30 days ]
    prostate cancer detection rate would be compared to that of a retrospetive cohort of patients who underwent prostate biopsy without the Navigo device.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age 18 years or older
  • Planned for trans-rectal prostate biopsy
  • Signed informed consent

Exclusion Criteria:

  • Patient's unwilling to participate
  • Patients with metal prosthetics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01480375

Contact: Ofer Nativ, Prof. 972-48359523

Bnai Zion medical center Recruiting
Haifa, Israel, 31048
Contact: Ofer Nativ, Prof.    972-4-8359523      
Sponsors and Collaborators
UC Care, Ltd.
Principal Investigator: Ofer Nativ, Prof. Bnai Zion Medical Center

Responsible Party: UC Care, Ltd. Identifier: NCT01480375     History of Changes
Other Study ID Numbers: 0053-11-BNZ
First Posted: November 28, 2011    Key Record Dates
Last Update Posted: January 16, 2013
Last Verified: January 2013

Keywords provided by UC Care, Ltd.:
prostate cancer detection
prostate biopsy
3d navigation
trans rectal ultrasound

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases