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