Prostate Cancer Diagnosis by Multiparametric Ultrasound (Wholemount)
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Multiparametric ultrasound (mp-US) data to identify sites of significant malignancy within the prostate
研究概览
简要总结
This phase III trial investigates if perflutren lipid microspheres with ultrasound can be used to diagnose prostate cancer non-invasively. Definity (perflutren lipid microspheres) is an ultrasound contrast agent that is typically used for ultrasound bubble studies that involve the heart. Definity appears on ultrasound images as tiny gas-filled microbubbles. These microbubbles are about the size of a red blood cell and do not stay in a patient's body for more than several minutes, where they are excreted from the lungs and exhaled back into the air when breathing. Definity may enhance ultrasound images of the prostate and help doctors identify prostate cancer on ultrasound images.
详细描述
PRIMARY OBJECTIVES:
I. To collect multiparametric ultrasound (mp-US) data on 70 patients within 30 days of their radical prostatectomy.
II. To correlate the imaging data with whole mount prostatectomy specimens in order to optimize mp-US with a machine learning approach.
OUTLINE:
Patients receive perflutren lipid microspheres intravenously (IV) over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres during ultrasound.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Subject must be scheduled for radical prostatectomy for treatment of prostate cancer
- •Subject must be able and willing to give written informed consent for a contrast enhanced ultrasound study of the prostate prior to prostatectomy
- •Subject must be a male at least 18 years of age when informed consent is obtained
排除标准
- •Participant in a clinical trial involving an investigational drug within the past 30 days
- •Patients with known or suspected hypersensitivity to perflutren, PEG, or any other component of Definity
- •Previous treatment for prostate cancer, including hormone therapy
- •Clinically unstable, severely ill, or moribund as per treating physician
研究组 & 干预措施
Diagnostic (perflutren lipid microspheres, ultrasound)
Patients receive perflutren lipid microspheres IV over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres
干预措施: Perflutren Lipid Microspheres (Drug)
Diagnostic (perflutren lipid microspheres, ultrasound)
Patients receive perflutren lipid microspheres IV over 5-6 minutes and undergo ultrasound over 30 minutes. Patients may receive up to 2 additional doses of perflutren lipid microspheres
干预措施: Ultrasound (Procedure)
结局指标
主要结局
Multiparametric ultrasound (mp-US) data to identify sites of significant malignancy within the prostate
时间窗: Up to 12 months
次要结局
未报告次要终点
研究者
Flemming Forsberg
Professor - Radiology
Thomas Jefferson University