PCMRI - an MRI/TRUS System for the Evaluation of the Prostate

Study Overview
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Brief Summary
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The aim of the clinical study is to evaluate the convenience and efficacy of the PCMRI in the assessment of the prostate in humans. The study cohort will include 50 patients and is designed to be non-comparative to other diagnostic methods.

Detailed Description
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Prostate cancer (PC) is the most common male malignancy in the western world. In the U.S. there are approximately 230,000 new diagnoses annually. Each year, 40,000 men with established disease die from PC. Early detection is possible using prostate specific antigen (PSA) and/or DRE, followed by biopsy if PC is suspected. Biopsy is generally carried out under transrectal ultrasound (TRUS) guidance through the rectum wall. Typically, 6-13 samples from different areas of the prostate are taken in order to cover the entire gland area. Since TRUS cannot accurately detect PC, prostate biopsies, to date, are in fact random biopsies. Furthermore, PSA may be elevated, in patients without PC, leading to as many as 75% of patients undergoing unnecessary TRUS guided biopsy [1,2]. The need for accurate preoperative evaluation of PC, as well as early detection of the tumor has lead to numerous applications of Magnetic Resonance Imaging (MRI) of the prostate.1 The sensitivity and specificity of whole body MRI with pelvic phased-array coils is as low as  70%. Improved sensitivity is obtained using an endorectal coil where efficacies of  85% are reported due to the improved signal to noise ratio (SNR) of such coils.2 One of the major limitations of conventional MRI scanners is their cost and limited availability. A portable, hand-held MR scanner capable of detecting PC is thus, of interest. TopSpin has developed a novel MRI based system for prostate imaging in Urology. The primary use of the prostate MRI probe will be diagnosis, staging and guidance of minimally invasive therapy for PC. The system consists of a miniaturized transrectal MRI probe, incorporating all magnetic field sources and coils. The MRI probe is integrated with and used in conjunction with a TRUS system. The TRUS probe provides prostate gross anatomy and allows the Urologist to select the cross-section(s) of interest within the prostate. The MRI probe provides MRI images of the selected cross-section(s) with improved tissue characterization that enable localizing tumors within the prostate. Fusion of both images has promise of significantly improving the ability to direct biopsies to regions of a much higher likelihood for being malignant. In addition, the system is capable of guiding local treatment such as Cryotherapy or Brachytherapy. The integrated MRI-TRUS system resembles a state-of-the-art, high-end ultrasound system. The MR-TRUS probe is connected to a cart based console, which houses the electronics hardware required for both MR and ultrasound activation. An investigational device will be manufactured, handled, and stored in accordance with applicable good manufacturing practice (GMP). It will be used in accordance with the approved protocol. Procedures that assure the quality of every aspect of the trial will be implemented.

Conditions
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Prostate Cancer

Intervention / Treatment
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* Device: PCMRI


Participation Criteria
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Eligibility Criteria
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Inclusion criteria for trial group: Age between 45 and 80 years old. Presumably Stage 2 and higher prostate carcinoma as determined by the PI. At least 6 weeks after the last biopsy session. Prior to any PC treatment. for control group: Age between 25 and 35 years old. No family history of PC. No lower urinary tract symptoms. Exclusion criteria for both groups: History of hemorrhoids. History of prostetitis

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: PCMRI<br> <br> |
| Experimental: 2<br> | Device: PCMRI<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of the PCMRI system in PC detection |  | one year | 
| Safety of the PCMRI system in PC detection |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient comfort |  | one year | 
| Compliance |  | one year | 
| Ease of use |  | one year | 
| Length of the test procedure |  | one year |