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临床试验/NCT03215992
NCT03215992已完成不适用

Diffuse Optical Tomography in Prostate Cancer Detection and Risk Stratification A Pilot Study

Columbia University1 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2016年6月13日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
9
试验地点
1
主要终点
Total number of subjects who are imaged using DOT and produce usable images

研究概览

简要总结

This study is looking to see if a new device, diffuse optical tomography (DOT), can detect prostate cancer. The investigators will also see if DOT can tell the difference between high risk and low risk prostate cancers.

详细描述

While some of these tools have helped to guide therapy in patients with prostate cancer, they are imperfect and as a result many men undergo unnecessary treatment for a disease that would not have caused their deaths. An improved method to risk stratify men with prostate cancer prior to definitive therapy may reduce the over-treatment rate, while maintaining or improving mortality.

Diffuse optical tomography (DOT) is a novel imaging modality that uses low-intensity, near-infrared light to characterize tissue. DOT analyzes the light being reflected and transmitted through tissue to generate three-dimensional images of chromophores and light scattering. As such, DOT serves as a functional imaging modality, measuring both tissue vascularity and architecture. The investigators believe that DOT will be able to detect prostate cancer in men suspected of the disease and will also be able to risk-stratify patients found to have prostate cancer to help guide treatment options. DOT may be able to directly measure two factors important in the prognosis of patients with prostate cancer: the Gleason score and microvessel density (MVD).

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Device Feasibility
盲法
None

入排标准

年龄范围
18 Years 至 99 Years(Adult, Older Adult)
性别
Male
接受健康志愿者
否

入选标准

  • •Men 18 years of age or older scheduled for transrectal prostate biopsy or radical prostatectomy at Columbia University Medical Center
  • •Signing consent for study imaging procedure and analysis of prostate biopsy

排除标准

  • •Patients failing to meet the inclusion criteria
  • •Contraindication for magnetic resonance imaging

研究组 & 干预措施

Men diagnosed with prostate cancer

Other

This group will include men over the age of 18 suspected of having prostate cancer who will undergo an ultrasound guided transrectal prostate biopsy. Each study participant will undergo a standard prostate biopsy and DOT imaging using the Diffuse Optical Tomography (DOT) System will be performed at the same time.

干预措施: Diffuse Optical Tomography (DOT) System (Device)

Men without prostate cancer

Other

This group will include men who do not have prostate cancer. Each study participant will undergo a standard prostate biopsy and DOT imaging using the Diffuse Optical Tomography (DOT) System will be performed at the same time.

干预措施: Diffuse Optical Tomography (DOT) System (Device)

结局指标

主要结局

Total number of subjects who are imaged using DOT and produce usable images

时间窗: Up to 3 years

Total number of subjects who produce usable images will be measured to assess feasibility of concurrent transrectal ultrasound guided (TRUS) biopsy/DOT imaging, which is defined as successfully imaging and generating usable DOT data in 60% of subjects.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Emerson Lim

Assistant Professor of Medicine

Columbia University

研究点 (1)

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