Urology of Virginia Case Series
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- Keyword Description of Each Biopsy Sample
研究概览
简要总结
The investigational protocol describes a small case series designed to compare three imaging modalities for use in visualizing prostate cancer.
The three modalities to be tested are: transrectal micro-ultrasound , and conventional resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI (mpMRI).
These modalities will be used for guiding systematic (standard, random, extended sextant) plus image-guided targeted prostate biopsies among men with known cancer and an indication for prostate biopsy.
In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the radiology report used for targeting.
详细描述
This trial will enroll nine men with an indication for a prostate biopsy.
The primary objective of the study is to provide guidance to clinicians who will be using the ExactVu system on the appearance of suspicious foci, and the difference between the appearance of these foci in LR-TRUS, mpMRI and transrectal micro-ultrasound images.
The study is being conducted based on the hypothesis that a series of same-subject comparisons will clearly demonstrate the differences in appearance between the modalities.
Procedures in the study are:
- obtain informed consent for the subject
- image the subject using mpMRI according to the PI-RADS v2 protocol, and obtain radiologist's report
- perform biopsy procedure using micro-ultrasound (this may be conducted in a separate subject visit)
- prepare biopsy specimens for pathology
- record all procedure details in a case report form, including pathology and mpMRI reports
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 79 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All men ≥ 40 years age and <80 years of age with a history of prostate cancer and an indication for a prostate biopsy will be offered inclusion in the study. Typical indications for biopsy include abnormal PSA (prostate specific antigen) and/or abnormal DRE (digital rectal exam) and/or history of prostate cancer.
- •Clinical stage < cT2c
排除标准
- •Patients will be excluded from being included in the investigation if any of the following is true:
- •Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia
- •Men with known prostate volume (from prior imaging) of > 60cc
- •Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
- •Men who are unable to provide their own informed consent
- •Men who have contraindications to MRI or gadolinium chelate contrast
结局指标
主要结局
Keyword Description of Each Biopsy Sample
时间窗: For each patient, keywords will be assigned within one week following the patient's procedure.
The primary endpoint will be a standardized description using keywords of each biopsy sample region. These descriptions will be recorded during the blinded readings after the procedure to avoid added procedure time and will be used to compare appearance between the modalities. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound.
次要结局
未报告次要终点