Robot-Assisted MRI-Guided Prostate Biopsy

NCT02080052 | Completed DMC

• 3 other identifiers: J11631RC1EB010936-01NA_00025078
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

Prostate biopsies are commonly performed freehanded under transrectal ultrasound guidance (TRUS). Due to the manual approach and the limitations of the ultrasound imager, the procedure has high false-negative rates. This represents a daily problem for urologists managing the disease, creates uncertainty and emotional stress for patients, and initiates a cascade of repeat testing and biopsies which also burden the investigators healthcare system. The investigators believe that prostate biopsy can be improved by using a new biopsy paradigm. The investigators plan to perform MRI-guided prostate biopsies with robot-assistance for orienting a needle-guide through which the biopsy is taken. The combination of MRI and robotic precision is expected to improve prostate biopsy sensitivity compared to regular TRUS biopsies. The study is a Pilot clinical trial on 5 patients to primarily assess feasibility and safety. The needle-guide robot is an investigational device developed in their Urology Robotics Laboratory.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (7)

• Number of participants with adverse events

  Three months

• Logged unsuccessful attempts to target prostate

  1 year

• Time for device setup, image registration, MRI time, biopsy sampling

  1 year

• Score for operation of the device

  Score assigned by the engineers on a 1 to 5 scale

  1 year

• Score for image deterioration

  Score assigned by radiologist on image quality on a 1 to 5 scale

  1 year

• Quality of the obtained biopsy specimen

  Score assigned by the pathologist on a 1-5 scale.

  1 year

• Overall grade of the device and procedure

  Grade give by urologist, radiologist and anesthesiologist on a 1-5 scale.

  1 year

Secondary Outcomes (5)

• Distance from the collected to planned biopsy core center measured on DICOM

  One year

• Number of needle trajectory corrections needed for alignment of each biopsy core

  1 year

• Number of diagnosed prostate cancers

  1 year

• Number of positive/total cores for each patient

  1 year

• Correlation of pathology findings with cancer specific region (CSR)s on MRI

  1 year

Study Arms (1)

Robot-assisted prostate biopsy

EXPERIMENTAL

Device: Robot-assisted prostate biopsy

Interventions

Robot-assisted prostate biopsy DEVICE

Robot-assisted prostate biopsy

Eligibility Criteria

• Age: 35 Years - 75 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• men between the ages of 35 and 75,
• have a negative 12 core prostate biopsy, and
• must have one of the following "high risk" features:
• PSA \>= 5.0 ng/ml and Prostate Volume \<= 50cc,
• PSA density \>= 0.2ng/ml/cc,
• Percent Free PSA \<=10%,
• PSA velocity \> 0.5 ng/ml/year,
• High Grade Prostate Intraepithelial Neoplasia on previous biopsy, or Atypia on previous biopsy.

You may not qualify if:

• bleeding problems,
• metal implants precluding MRI scanning,
• previous rectal surgery, anal stenosis that precludes endorectal coil insertion,
• patients who cannot tolerate anesthesia or in whom anesthesia is considered high-risk, and
• patients who are unwilling or unable to sign informed consent.

Sponsors & Collaborators

• Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

The Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Related Publications (10)

• Srimathveeravalli G, Kim C, Petrisor D, Ezell P, Coleman J, Hricak H, Solomon SB, Stoianovici D. MRI-safe robot for targeted transrectal prostate biopsy: animal experiments. BJU Int. 2014 Jun;113(6):977-85. doi: 10.1111/bju.12335. Epub 2013 Dec 2.

  PMID: 24118992 BACKGROUND

• Kim C, Chang D, Petrisor D, Chirikjian G, Han M, Stoianovici D. Ultrasound probe and needle-guide calibration for robotic ultrasound scanning and needle targeting. IEEE Trans Biomed Eng. 2013 Jun;60(6):1728-34. doi: 10.1109/TBME.2013.2241430. Epub 2013 Jan 21.

  PMID: 23358940 BACKGROUND

• Stoianovici D. Technology advances for prostate biopsy and needle therapies. J Urol. 2012 Oct;188(4):1074-5. doi: 10.1016/j.juro.2012.06.127. Epub 2012 Aug 15. No abstract available.

  PMID: 22901579 BACKGROUND

• Bonekamp D, Jacobs MA, El-Khouli R, Stoianovici D, Macura KJ. Advancements in MR imaging of the prostate: from diagnosis to interventions. Radiographics. 2011 May-Jun;31(3):677-703. doi: 10.1148/rg.313105139.

  PMID: 21571651 BACKGROUND

• Badaan S, Petrisor D, Kim C, Mozer P, Mazilu D, Gruionu L, Patriciu A, Cleary K, Stoianovici D. Does needle rotation improve lesion targeting? Int J Med Robot. 2011 Jun;7(2):138-47. doi: 10.1002/rcs.381. Epub 2011 Mar 1.

  PMID: 21360796 BACKGROUND

• Cunha JA, Hsu IC, Pouliot J, Roach Iii M, Shinohara K, Kurhanewicz J, Reed G, Stoianovici D. Toward adaptive stereotactic robotic brachytherapy for prostate cancer: demonstration of an adaptive workflow incorporating inverse planning and an MR stealth robot. Minim Invasive Ther Allied Technol. 2010 Aug;19(4):189-202. doi: 10.3109/13645706.2010.497000.

  PMID: 20642386 BACKGROUND

• Stoianovici D, Song D, Petrisor D, Ursu D, Mazilu D, Muntener M, Schar M, Patriciu A. "MRI Stealth" robot for prostate interventions. Minim Invasive Ther Allied Technol. 2007;16(4):241-8. doi: 10.1080/13645700701520735.

  PMID: 17763098 BACKGROUND

• Stoianovici D, Patriciu A, Petrisor D, Mazilu D, Kavoussi L. A New Type of Motor: Pneumatic Step Motor. IEEE ASME Trans Mechatron. 2007 Feb 1;12(1):98-106. doi: 10.1109/TMECH.2006.886258.

  PMID: 21528106 BACKGROUND

• Muntener M, Patriciu A, Petrisor D, Mazilu D, Bagga H, Kavoussi L, Cleary K, Stoianovici D. Magnetic resonance imaging compatible robotic system for fully automated brachytherapy seed placement. Urology. 2006 Dec;68(6):1313-7. doi: 10.1016/j.urology.2006.08.1089.

  PMID: 17169653 BACKGROUND

• Ball MW, Ross AE, Ghabili K, Kim C, Jun C, Petrisor D, Pan L, Epstein JI, Macura KJ, Stoianovici DS, Allaf ME. Safety and Feasibility of Direct Magnetic Resonance Imaging-guided Transperineal Prostate Biopsy Using a Novel Magnetic Resonance Imaging-safe Robotic Device. Urology. 2017 Nov;109:216-221. doi: 10.1016/j.urology.2017.07.010. Epub 2017 Jul 19.

  PMID: 28735018 RESULT

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

• Mohamad E Allaf, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Mark W Ball, MD

  Johns Hopkins University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2014
• First Posted: March 6, 2014
• Study Start: July 25, 2013
• Primary Completion: January 1, 2016
• Study Completion: January 1, 2016
• Last Updated: January 14, 2019

Record last verified: 2019-01

Locations

US (1)