ClariCore System Used in Transrectal Ultrasound Guided Prostate Biopsy for Real-Time Tissue Evaluation (SCORE)

February 12, 2019 updated by: Precision Biopsy, Inc.

Prospective, Multi-Center Study of the ClariCore Optical Biopsy System in Patients Undergoing Transrectal Ultrasound (TRUS)-Guided Prostate Biopsy for Real-Time Tissue Evaluation

The purpose of this study is to demonstrate the effectiveness and safety of the ClariCore System in obtaining prostate biopsies with device feedback that provides real-time tissue classification.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The purpose of this study is to collect information on prostate biopsies using the ClariCore System. The ClariCore System is designed to improve how the biopsies are being collected from the prostate by using light sensors (fiber optics) that can see changes in the prostate tissue. Researchers will study the information collected from the light sensors to study a method that has been developed to tell the difference between normal and suspicious (possibly cancerous) prostate tissue during the biopsy. This information will be given to the doctor in real-time. From this study, researchers hope to learn if this method can tell the difference between normal and suspicious prostate tissue, and if this can improve the evaluation of prostate tissue (biopsies).

Study Type

Interventional

Enrollment (Anticipated)

325

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Colorado
      • Denver, Colorado, United States, 80211
        • Recruiting
        • The Urology Center of Colorado
        • Contact:
          • Robin Dorsey
          • Phone Number: 303-762-7155
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Not yet recruiting
        • Brady Urological Institute, Johns Hopkins Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Michael A Gorin, M.D., Ph.D.
    • New York
      • New York, New York, United States, 10016
      • New York, New York, United States, 10021
        • Not yet recruiting
        • Memorial Sloan-Kettering Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Bafar Edhaie, M.D.
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Urologic Research Center
        • Contact:
        • Sub-Investigator:
          • Kenneth Krzyzaniak, MD
    • Texas
      • San Antonio, Texas, United States, 78229

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

22 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Males > 22 years old
  • Patient scheduled for TRUS-guided prostate biopsy based on standard of care urologic requirements to assess for tissue malignancy (abnormal Digital Rectum Examination, Prostate Specific Antigen kinetics, age, ethnicity, family history, etc.)
  • Enrolling physician must have expectation that prostate dimensions will meet minimum prostate volume and height requirements that will be evaluated at start of biopsy procedure (i.e., Prostate volume > 20cc and height at least 22mm)
  • Patient signs an Institutional Review Board approved, Informed Consent form to participate in the study prior to any study mandated determinations or procedure

Exclusion Criteria:

  • Any anatomical or co-morbidity contraindications to TRUS prostate biopsy
  • Acute painful perianal disorder (i.e. rectal abscess)
  • Symptomatic, acute prostatitis
  • Surgical absence of a rectum or the presence of a rectal fistula
  • Patient has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
  • Previous prostate intervention [Transurethral Prostatectomy (TURP) (bipolar, monopolar, laser)], Transurethral Microwave Thermotherapy (TUMT), High-Intensity Focused Ultrasound (HIFU), Cryo, Rezum, Urolift], not including previous prostate biopsy
  • Current use of blood thinning agents for medical comorbidity which prohibits the cessation of use as typically required per standard of care (SOC) or history of a bleeding disorder (e.g. coagulopathy)
  • Prior pelvic irradiation
  • Actively receiving therapy for the treatment of cancer (except for patients on 5-alpha reductase inhibitors, or non-melanoma skin cancers that are managed nonsystemically)
  • Actively receiving intravesical therapy or within 6 months of treatment for bladder cancer
  • Patient has compromised immune system
  • Active inflammatory bowel disease within the last 6 months
  • Any condition, or history of illness or surgery that, in the opinion of the Investigator, might confound the results of the study or pose additional risks to the patient (e.g. significant cardiovascular conditions or allergies)
  • Patient is not likely to comply with the protocol or follow up evaluation
  • Patient is participating in a clinical trial of another investigational drug or device that may impact participation in this clinical study
  • Patient is unable to provide legal Informed Consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: ClariCore System
ClariCore System study designed to obtain prostate biopsies utilizing real-time tissue classification with the ClariCore Optical Biopsy System.
Device: ClariCore Optical Biopsy System
Demonstrate the efficacy and safety of the ClariCore System in obtaining prostate biopsies utilizing real-time tissue classification.
Other Names:
  • ClariCore System

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Validation of the tissue classification algorithm
Time Frame: At time of procedure
Correlate histopathology of tissue biopsy core samples with the tissue classification algorithm results obtained at the time of the procedure to validate the tissue classification algorithm.
At time of procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity
Time Frame: At time of procedure
The sensitivity and specificity of the ClariCore System will be calculated and reported.
At time of procedure
Cancer Detection Rate
Time Frame: At time of procedure
The cancer detection per core rate in the Targeted Cores that have been classified as suspicious will be determined and reported.
At time of procedure

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Identification of New or Clinically Significant Disease
Time Frame: At time of procedure, at time of 7 day follow up
The number of instances where a new or more clinically significant disease (Gleason 7 or greater) is diagnosed during collection of the Targeted Cores compared to the SOC Cores
At time of procedure, at time of 7 day follow up
Adverse Event Incidence
Time Frame: Up to 7 days post-procedure
The cumulative incidence of adverse events related to the device or the procedure.
Up to 7 days post-procedure
Serious Adverse Event
Time Frame: Up to 7 days post-procedure
The cumulative incidence of serious adverse events (SAEs) related to the device or the procedure.
Up to 7 days post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Precision Biopsy, Inc.

Investigators

  • Principal Investigator: Neal Shore, M.D., Carolina Urologic Research Center/Atlantic Urology Clinics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

April 25, 2018

Primary Completion (ANTICIPATED)

January 1, 2020

Study Completion (ANTICIPATED)

December 1, 2020

Study Registration Dates

First Submitted

April 6, 2018

First Submitted That Met QC Criteria

April 12, 2018

First Posted (ACTUAL)

April 20, 2018

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 12, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP-1010-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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