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临床试验/NCT02013414
NCT02013414已完成不适用

Molecular Image-directed, 3D Ultrasound-guided Biopsy of the Prostate

Emory University2 个研究点 分布在 1 个国家目标入组 9 人开始时间: 2013年9月最近更新:
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
2
主要终点
Cancer Detection by Targeted and Standard Biopsy Approaches

研究概览

简要总结

The objective of the proposed study is to evaluate a new, molecular image directed, three-dimensional (3D) ultrasound guided biopsy system in human patients. The current biopsy uses ultrasound imaging as guidance. However, the procedure uses two-dimensional (2D) ultrasound images and has sampling errors thus some cancers can be missed from the standard 2D image-guided biopsy. In this study, an FDA-approved ultrasound device will be used to obtain three-dimensional (3D) images of the prostate from a commercially available ultrasound scanner. The clinician can use the 3D images to guide biopsy, record the core location of the biopsy sites, and perform re-biopsy to the same sites in a patient follow-up examination. This system can also use images from magnetic resonance imaging (MRI) or positron emission tomography (PET) and then fuse PET or MR images with 3D ultrasound images to guide the needle to a suspicious tumor target as seen on MRI or PET. We think that this fusion targeted biopsy technology will help to improve the accuracy of the current systematic biopsy approach for prostate cancer detection.

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

入选标准

  • Patients must be 18 years or older
  • Abnormal uptake in prostate necessitating a biopsy
  • Able to provide informed consent

排除标准

  • Age less than 18
  • Cannot provide informed consent
  • Less than 2 months since any prior prostate biopsy (to decrease false positive uptake from inflammation)

研究组 & 干预措施

3D ultrasound-guided biopsy

Experimental

Participants will have a 3D ultrasound-guided biopsy of the prostate rather than the standard of care 2D ultrasound-guided biopsy.

干预措施: 3D ultrasound-guided biopsy (Device)

结局指标

主要结局

Cancer Detection by Targeted and Standard Biopsy Approaches

时间窗: Up to 2 years

The feasibility of detecting cancer detection with the targeted prostate biopsy was assessed. This study sought only to determine if the targeted biopsy approach was able to detect recurrent prostate cancer and values for the number of samples testing positive for cancer per each biopsy approach are not available. This feasibility study preceded a clinical trial (NCT02744534) assessing the accuracy of prostate cancer detection with targeted biopsies compared to the standard biopsy.

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

Baowei Fei, PhD, EngD

Associate Professor and Georgia Cancer Coalition Dinstinguished Cancer Scholar

Emory University

研究点 (2)

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