Cellular Diagnosis, Prostate Cancer
Conditions
Brief summary
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.
Detailed 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.
Interventions
DEVICEClariCore System
Data collection to build the prostrate tissue classification algorithm.
Sponsors
Precision Biopsy, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
22 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Primary Effectiveness | Ath the time of procedure | Correlate histopathology of tissue biopsy core samples with corresponding spectral data obtained in vivo for algorithm training at time of procedure. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Pain | Up to 30 days post-procedure | Pain shall be reported based on the patient-reported level of pain during the ClariCore System procedure and at 7 and 30 days post-procedure as measured on a 10 point numerical rating scale (NRS). |
| Incidence and frequency of adverse events | Up to 30 days post-procedure | The secondary safety endpoint is the incidence and frequency of all Adverse Event's (both related and unrelated to the ClariCore System) reported during the study. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Technical Success | Until clinical study closure, at time of 30 day follow up | Ability to obtain optical spectra: defined as the ability to obtain the optical spectra of underlying tissue at each target site and record and store the data on the software and obtain viable biopsy sample from the underlying tissue where the optical spectra data were collected: defined as a sample that the pathologist can use to classify the specific tissue. |
| Clinical Success | Until clinical study closure, at time of 30 day follow up | Clinical success is defined at the biopsy core level as the device's ability to obtain a technically successful core and an accurate correlation with optical spectra for the purpose of the tissue classification development. |
| Negative Predictive Value | Until clinical trial closure, at time of 30 days follow up | The negative predictive value (NPV) will be estimated as a function of prevalence. |
Countries
United States
Outcome results
None listed