A Pilot Trial Evaluation of Ultrasound Elasticity/Tissue Strain-Hardening Imaging for Prostate Cancer in Patients Undergoing Radical Prostatectomy
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Evaluation of diagnostic technique (using tissue elastography) for prostate cancer detection in men scheduled to undergo a radical prostatectomy
研究概览
简要总结
The primary objective is to perform a pilot trial evaluation of a novel prostate ultrasound imaging software utilizing tissue elasticity measurements to identify tumor foci among men who will undergo radical prostatectomy for localized prostate cancer.
As a secondary objective, investigators will compare elasticity measured tumor foci volume to the measured volume from radical prostatectomy pathologic examination.
详细描述
Study Imaging:
As part of routine care, ultrasound scanning is commonly used to find the cancerous areas of the prostate before the prostate is surgically removed. The ultrasound images are in black, white, and gray, and the dark areas may show prostate cancer.
In this study, standard ultrasound scanning will still be done, but researchers want to test another form of diagnostic imaging called tissue elastography.
Tissue elastography uses the same machine and probe as the ultrasound. The probe is gently pushed through the rectum and into the prostate gland (similar to a digital rectal exam). The ultrasound machine will use a special elastography software that is designed to scan the prostate for differences in how hard the tissue is. Prostate cancer tissue may be harder than surrounding tissue, and the images produced by tissue elastography are designed to show these differences in hardness of tissue.
Screening:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients selected for radical prostatectomy (any technique) at MDACC
- •Histologic diagnosis of prostate cancer, clinical stage cT1c-cT3b
- •Serum prostate specific antigen less than 30 ng/ml.
- •Any Gleason score
- •Total prostate volume of 20-60 cc, measured by outside ultrasound or clinical examination at MDACC.
- •Group 1: high volume disease. At least 3 positive cores containing cancer on one side of the prostate Group 2: low volume disease. Less than 50% tumor length in a single positive core on one side of the prostate
排除标准
- •Prior radiation therapy to the pelvis
- •Prior hormonal therapy within 3 months (including LH/RH agonists, estrogens, testosterone receptor blockade, finasteride, dutasteride)
结局指标
主要结局
Evaluation of diagnostic technique (using tissue elastography) for prostate cancer detection in men scheduled to undergo a radical prostatectomy
时间窗: 2 Years
Pilot evaluation of novel prostate ultrasound imaging software utilizing tissue elasticity measurements to identify tumor foci among men who will undergo radical prostatectomy for localized prostate cancer. The methods of Bland and Altman (1986) used to assess whether the tumor volume estimated by the ultrasound imaging technique agrees with the tumor volume measured at pathology. An ultrasound based elasticity measurement technique will detect differences in prostate hardness by using sophisticated mathematical techniques to analyze ultrasound images obtained before and after small compressions of the prostate gland with the ultrasound probe, detecting differences in hardness by measuring relative displacements of portions of the gland. Elasticity images obtained during standard, medically-indicated prostate sonography.
次要结局
未报告次要终点