跳至主要内容
临床试验/NCT00542100
NCT00542100Unknown不适用

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

TopSpin Medical0 个研究点目标入组 50 人开始时间: 2007年11月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
50
主要终点
Efficacy of the PCMRI system in PC detection

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
25 Years 至 80 Years(Adult, Older Adult)
性别
Male
接受健康志愿者

入选标准

  • 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.

排除标准

  • for both groups:
  • History of hemorrhoids.
  • History of prostetitis

结局指标

主要结局

Efficacy of the PCMRI system in PC detection

时间窗: one year

Safety of the PCMRI system in PC detection

时间窗: one year

次要结局

  • Patient comfort(one year)
  • Compliance(one year)
  • Ease of use(one year)
  • Length of the test procedure(one year)

研究者

发起方
TopSpin Medical
申办方类型
Industry

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