A Pilot Study to Evaluate the Imaging Capability of a Novel Prostate-targeted PET System (P-PET) to Detect Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Qualitative comparison of PET scans acquired by the P-PET vs. WB PET
研究概览
简要总结
The goal of this study is to evaluate the imaging capabilities of a new prostate-targeted PET system (P-PET) and determine whether it could be useful in detecting prostate cancer by comparing SOC whole body PET imaging. This pilot study will include adult men who have been diagnosed with or are suspected to have prostate cancer. Participants will undergo a standard-of-care PET/CT scan followed by an additional P-PET scan designed to provide detailed images of the prostate. The images from the two scans to assess how well the P-PET system can detect prostate cancer.
详细描述
This pilot study will evaluate the performance of a novel prostate-targeted positron emission tomography (PET) imaging system (P-PET) in men undergoing PET imaging for primary staging of prostate cancer. This study is designed to assess the feasibility and diagnostic performance of this new imaging approach.
Participants will receive the standard-of-care PET radiotracer fluroine-18 PSMA-1007 (18F-PSMA-1007) as part of routine clinical PET imaging. While the tracer is circulating in the body, a research dynamic imaging sequence will be performed, followed by the standard-of-care whole body PET scan. Immediately after completion of the standard imaging, participants will undergo the research P-PET scan during the same imaging visit. No additional radiotracer will be administered for the P-PET scan, as it used the same tracer injection given for the standard-of-care PET imaging.
Images obtained from the P-PET system will undergo comparative analysis with the standard-of-care PET scan images to assess lesion detection, image quality and overall imaging performance. The findings from this study will provide preliminary data on feasibility and potential diagnostic value of the P-PET system and may guide future research in prostate-targeted PET imaging.
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
盲法说明
This is an open-label study. Both participants and study staff will know that all participants are receiving clinical PSMA PET/CT, research dynamic PET, and research P-PET scans.
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Qualitative comparison of PET scans acquired by the P-PET vs. WB PET
排除标准
- •Unable to comply with the length of scan time due to the study imaging.
研究组 & 干预措施
Standard-of-care PET Scan with Additional Dynamic and P-PET imaging.
This is a prospective, single-arm, pilot diagnostic study to evaluate the diagnostic study to evaluate the diagnostic accuracy of using dynamic PET, and P-PET in 25 patients with biopsy proven prostate cancer. This study will take place during the scheduled routine clinical PSMA PET/CT scan.
干预措施: Prostate-Targeted PET- Scan (P-PET). (Diagnostic Test)
结局指标
主要结局
Qualitative comparison of PET scans acquired by the P-PET vs. WB PET
时间窗: Baseline (Day1)
The primary outcome is the detection of prostate cancer lesions by the research prostate-targeted P-PET scan. Images from the P-PET scan will be compared to standard-of-care PET scan images to evaluate the sensitivity and clarity of the new imaging system in identifying cancerous lesions in the prostate.
次要结局
- Number of Prostate Lesions Detected by P-PET Compared with Standard-of-care Whole-Body PET(Baseline (Day 1))
研究者
Stephen Pautler
Urologist, St. Joseph's Health Care London
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's