Molecular Image-directed, 3D Ultrasound-guided Biopsy of the Prostate
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
- 否
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
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
Baowei Fei, PhD, EngD
Associate Professor and Georgia Cancer Coalition Dinstinguished Cancer Scholar
Emory University
