Feasibility Study of Prostate Tumor Localization for Focal Cryoablation of Prostate Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 65
- 试验地点
- 2
- 主要终点
- Improved Accuracy of Prostate Cancer Detection by MRI Scan.
研究概览
简要总结
The purpose of the present study is to find out if MRI techniques examining (1) the motion of water molecules in the prostate (diffusion sensitive MRI), (2) the difference in blood flow to the prostate (dynamic contrast enhanced MRI), and (3) differences in chemical composition of the prostate (MR spectroscopy), can be used to detect prostate cancer early and non-invasively. Localization of the cancer within the prostate would be of particular importance in focal cryoablation of prostate carcinoma which we hope to improve as a result of this project.
Additional aim of the study is to correlate expression of genes believed to pay a role in prostate cancer with MRI findings.
详细描述
Radical prostatectomy patients will undergo an MRI prior to their scheduled surgery. Ex vivo imaging will be done on prostates once removed. Results from the final pathology with be compared with results of imaging to determine the accuracy of the image analysis in cancer localization and staging.
Brachytherapy patients will undergo an MRI prior to their scheduled procedure. Two areas of suspected cancer and two areas without suspected cancer will be prospectively identified based on the MRI imaging. At the time of brachytherapy, transrectal needle biopsies will be obtained from the previously identified areas. The needle cores will be reviewed by study pathologist to determine the accuracy of the image analysis in cancer localization and staging.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 85 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •patients who have been diagnosed with prostate cancer and are scheduled for radical prostatectomy or for brachytherapy
- •patients who have not received any preoperative treatment for their diagnosis of prostate cancer
排除标准
- •patients with implants that are electronically, magnetically, or mechanically active
- •patients with intracranial aneurysm clips
- •patients who have undergone cosmetic eyelid surgery
- •patients with history of pheochromocytoma, insulinoma and acute glaucoma
- •patients with estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2
研究组 & 干预措施
Radical prostatectomy patients
Patients who have been diagnosed with prostate cancer and are scheduled to undergo radical prostatectomy and have not received any preoperative treatment for prostate cancer.
干预措施: MRI scan (Device)
Brachytherapy patients
Patients who have been diagnosed with prostate cancer and are scheduled to undergo brachytherapy and have not received any preoperative treatment for prostate cancer.
干预措施: MRI scan (Device)
结局指标
主要结局
Improved Accuracy of Prostate Cancer Detection by MRI Scan.
时间窗: At time of treatment
Data obtained as part of this study could not be analyzed in a meaningful way due to problems with correlation between the cancerous tissue identified by histology and tissue imaging from imaging.
次要结局
- Successful MRI Guidance of Transrectal Ultrasound Biopsy in Patients.(At time of treatment)