Feasibility of OmnEcoil System for Integrated Endorectal MRI and Transrectal MRI-Targeted Biopsy of the Prostate
试验速览
- 阶段
- 不适用
- 状态
- 暂停
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Incidence of biopsy-related grade >= 3 adverse events (traditional feasibility study)
研究概览
简要总结
This clinical trial tests whether it is feasible to use the OmnEcoil system for transrectal magnetic resonance imaging (MRI) to visualize and biopsy suspicious lesions in the prostate. The OmnEcoil device combines an endorectal coil (a type of wire placed within the rectum during diagnostic endorectal MRI to take better images of the prostate) with an endorectal probe. The OmnEcoil system is designed to allow for MRI to be used at the same time to image the prostate and aid in the biopsy of the suspected prostate cancer. Usually, these are performed as two separate events at two separate times.
详细描述
PRIMARY OBJECTIVES:
I. To demonstrate that the OmnEcoil system can obtain diagnostic tissue samples in vivo. (Early Feasibility Study)
II. To evaluate physician experience using OmnEcoil system. (Early Feasibility Study)
III. To monitor the safety of the OmnEcoil system. (Early Feasibility Study)
IV. To determine the performance of the OmnEcoil system as measured by the acquisition of diagnostic tissue samples and cancer containing biopsies of target lesions. (Traditional Feasibility Study)
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males, aged >= 45 years
- •Willing and able to provide written informed consent, including willingness to undergo MRI-targeted biopsy using OmnEcoil investigational system
- •Persistently elevated (> 3 ng/mL) or rising prostate specific antigen (PSA) level and/or abnormal digital rectal exam
- •Prior negative transrectal ultrasound (TRUS) biopsy, or prior TRUS biopsy or transurethral resection of the prostate showing Gleason score =< 6 disease
- •Received multiparametric prostate MRI within last 6 months prior to study enrollment with images available on Oregon Health and Science University (OHSU) image viewing system for review
- •Must have at least one high-value biopsy target (i.e., score of 4 or 5 as categorized by Prostate Imaging and Reporting and Data System [PI-RADS] version 2.1) present on multiparametric MRI as evaluated by study radiologists
- •Eastern Cooperative Group (ECOG) performance score 0 or 1
- •Patient able to lie prone in MRI for OmnEcoil biopsy procedure
- •Considered to be low bleeding risk [per Society for Interventional Radiology], including:
- •International normalized ratio (INR) <= 1.5, and
- •Platelets >= 50,000
排除标准
- •Contraindication to MRI (e.g., severe claustrophobia, intracranial aneurysm clips, intraocular metallic foreign body, and cardiac pacemaker)
- •Any contraindication to endorectal devices and/or biopsy, including (but not limited to) severe hemorrhoids, anal fissure, recent rectal surgery, or prior abdominoperineal resection
- •Any bleeding diathesis and/or anti-coagulative therapy that cannot be temporarily reversed
- •Active infection requiring systemic antibiotic therapy. Participants requiring systemic antibiotics for infection must have completed antibiotic therapy before initiating OmnEcoil imaging/biopsy procedure
- •Administration of treatment for prostate cancer such as radiation or hormonal therapy prior to MRI-targeted biopsy
- •Uncontrolled intercurrent illness that would substantially increase risk of incurring adverse events (AEs), confound results, or compromise the ability of the patient to give written informed consent
- •Subjects unwilling to accept a blood transfusion
研究组 & 干预措施
Diagnostic (endorectal MRI, MRI-targeted biopsy)
Patients undergo endorectal MRI and transrectal MRI-targeted biopsy using the OmnEcoil device.
干预措施: Endorectal Magnetic Resonance Imaging (Procedure)
Diagnostic (endorectal MRI, MRI-targeted biopsy)
Patients undergo endorectal MRI and transrectal MRI-targeted biopsy using the OmnEcoil device.
干预措施: Biopsy (Device)
结局指标
主要结局
Incidence of biopsy-related grade >= 3 adverse events (traditional feasibility study)
时间窗: Up to 30 days after end of procedure
Assessed per Common Terminology Criteria for Adverse Events version 5.0.
Successful acquisition of tissue samples (early feasibility study)
时间窗: Start of procedure to end of procedure, an average of less than 1 day
Conducted with 10 subjects to demonstrate that OmnEcoil system can be used to obtain diagnostic tissue samples.
Physician device-user scores (early feasibility study)
时间窗: Start of procedure to end of procedure, an average of less than 1 day
Physician will rate device using a scale from 1 (excellent) to 5 (poor) following completion of OmnEcoil guided biopsy.
Successful acquisition of diagnostic tissue samples (traditional feasibility study)
时间窗: Start of procedure to end of procedure, an average of less than 1 day
Procedure success determined by pathological review establishing that the samples are adequate for diagnosis. Criteria for acceptance is success rate \>= 90%.
Presence of cancer containing biopsies of dominant targets (traditional feasibility study)
时间窗: Start of procedure to end of procedure, an average of less than 1 day
Criteria for acceptance is proportion of cancer containing biopsies \>= 76%.
Incidence of biopsy-related grade >= 3 adverse events (early feasibility study)
时间窗: Up to 30 days after end of procedure
Assessed per Common Terminology Criteria for Adverse Events version 5.0.
次要结局
未报告次要终点
研究者
Fergus Coakley
Principal Investigator
OHSU Knight Cancer Institute