A Novel 3D Navigation Technology for Improved TRUS Prostate Biopsy

NCT01480375 | Completed

• 1 other identifier: 0053-11-BNZ
• Study Type: interventional
• Target: 524
• Locations: 1 country
• Sites: 1

Brief Summary

he 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.

Conditions

Prostate Cancer

Keywords

prostate cancer detection; prostate biopsy; 3d navigation; trans rectal ultrasound

Outcome Measures

Primary Outcomes (1)

• increased prostate cancer detection rate

  prostate cancer detection rate would be compared to that of a retrospetive cohort of patients who underwent prostate biopsy without the Navigo device.

  30 days

Study Arms (2)

Navigo™ and Smartbx™ system.

EXPERIMENTAL

all biopsy cores were handled using the Smartbx™ system. part of the procedures were performed with both Navigo™ and Smartbx™ system.

Device: Smartbx™ system.

standard method

NO INTERVENTION

all biopsy cores were handled using standard method - shaking the biopsy needle into formalin vial. no navigation system.

Interventions

Smartbx™ system. DEVICE

The SmartBx™ system semi-automated downloads the biopsy cores from the biopsy needle onto a designated cassette which integrates into the routine pathology lab processing. The core is downloaded in an oriented and straightened fashion while preserving core fragments in its original locations relative to the needle notch.

Navigo™ and Smartbx™ system.

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• UC Care, Ltd.: lead

Study Sites (1)

Bnai Zion medical center

Haifa, 31048, Israel

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Ofer Nativ, Prof.

  Bnai Zion Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2011
• First Posted: November 28, 2011
• Study Start: September 22, 2011
• Primary Completion: November 15, 2017
• Study Completion: November 15, 2017
• Last Updated: April 19, 2019

Record last verified: 2018-05

Locations

IL (1)