ClariCore Optical Biopsy System Used in TRUS (Trans-Rectal Ultrasound)-Guided Prostrate Biopsy

Precision Biopsy

Status

Unknown

Conditions

Cellular Diagnosis, Prostate Cancer

Treatments

Device: ClariCore System

Study type

Interventional

Funder types

Industry

Identifiers

NCT02928640

CIP-1010

Details and patient eligibility

About

The purpose of the study is to collect information on prostrate biopsy tissue for use in developing a method determining the difference in normal and cancerous prostrate tissue using the ClariCore System.

Full description

The purpose of this study is to collect information on prostrate tissue biopsies using the ClariCore System. The ClariCore system is designed to improve how the tissue samples are being collected from the prostrate by using light sensors (fiber optics) that can see changes in the tissue. Researchers will study the data collected from the light sensor (optical readings) to develop a method (like a mathematical equation) that can be used to tell the difference between normal and cancerous prostrate tissue during the biopsy. What the researchers are hoping to learn from this study is if a light guided biopsy procedure can improve the accuracy of prostrate biopsy sampling.

Enrollment

200 estimated patients

Sex

Male

Ages

22+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patient scheduled for TRUS-guided prostrate biopsy with or without MR TRUS Fusion determined based on standard of care requirements
Prostrate volume ≥ 20cc and height at least 22mm (at the area(s) to be biopsied) as verified by ultrasound or prostrate MRI
Patient, or authorized representative signs a written Informed Consent form to participate in the study, prior to any study mandated determinations or procedure

Exclusion criteria

Contraindications to TRUS prostrate biopsy
- Acute painful perianal disorder
- Surgical absence of a rectum or the presence of a rectal fistula
Patients with contraindications to MRI (e.g., pacemaker, claustrophobia, etc.) (MR/TRUS only)

---Patients with renal dysfunction are excluded due to their inability to undergo contrast enhanced MRI
Previous prostrate surgeries
Prior pelvic irradiation
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 has systemic infection or evidence of any surgical site infection (superficial or organ space), including active urinary tract infection
Bladder cancer (current or prior)
Symptomatic acute prostatitis
Actively taking blood thinning agents (with the exception of low dose aspirin [81 mg] Plavix, Coumadin, etc.) or severe comorbidity prohibiting halting of anticoagulation therapies or history of bleeding disorder (e.g., coagulopathy
Any malignancy other than non-melanoma cell skin cancer, unless no evidence of disease for a minimum of 5 years
Hormone therapy for locally advanced disease (except patients on 5-alpha reductase inhibitors to reduce the size of the prostrate)
Neo-adjuvant hormonal therapy
Salvage radical prostatectomy, i.e., patients having surgery due to failure of previous therapy (radiation, brachytherapy, cryotherapy, etc.)
Patient has a compromised immune system or autoimmune disease (WBC < 4000 or > 20,000)
Patient is not likely to comply with the follow-up evaluation schedule
Patient is participating in a clinical trial of another investigational drug or device
Patient is mentally incompetent or a prisoner