A Prospective Study of the RefleXion [18F]- DCFPyL PET-CT Subsystem Imaging Performance in Patients With Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Number of Participants With Tumor Visualized on X1 RefleXion Medical Radiotherapy System (RMRS) Positron Emission Tomography-computed Tomography (PET-CT)
研究概览
简要总结
This clinical trial examines RefleXion Medical Radiotherapy System (RMRS) imaging to the standard of care (SOC) [18F]-DCFPyL positron emission tomography-computed tomography (PET-CT) imaging in patients with prostate cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of a tracer, [18F]-DCFPyL, that binds to prostate specific membrane antigen (PSMA) on tumor cells. These PSMA tumor cells can then be identified on PET imaging. CT utilizes x-rays that traverse body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in patient's body. The RMRS is a imaging-therapy combination system that can plan for and deliver radiation therapy as well perform [18F]-DCFPyL PET-CT imaging. Comparing the imaging from the standard of care [18F]-DCFPyL-PET-CT with the [18F]-DCFPyL imaging from RMRS may help improve the quality of the imaging captured and determine if imaging can be done on the RMRS at the same time as planning for radiation therapy, which would reduce the number of scans needed to plan for radiation for prostate cancer.
详细描述
PRIMARY OBJECTIVE:
I. To assess imaging performance of the fluorine F 18 piflufolastat ([18F]-DCFPyL) PET-CT subsystem on the X1 RMRS to detect lesions (primary and metastatic) in patients with prostate cancer.
SECONDARY OBJECTIVE:
I. To determine the feasibility of generating a biology-guided radiotherapy (BgRT) plan using X1 RMRS-acquired [18F]-DCFPyL PET data derived from the imaging-only session at the studied dose level.
OUTLINE:
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
- 21 Years 至 —(Adult, Older Adult)
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Documented informed consent of the participant and/or legally authorized representative
- •Age >= 21 years
- •Patients undergoing SOC [18F]-DCFPyL PET-CT
- •Patients should be scheduled for [18F]-DCFPyL PET-CT prior to study entry
排除标准
- •Known psychiatric or substance abuse disorder that would interfere with conduct of the study
- •Patient weight exceeding the weight limit (450 pounds) outlined per X1 RMRS specifications sheet
研究组 & 干预措施
Diagnostic ([18F]-DCFPyL PET-CT, X1 RMRS PET-CT)
Patients receive [18F]-DCFPyL IV and undergo [18F]-DCFPyL PET-CT over 30 minutes per SOC. Patients with PET avid lesions then undergo a X1 RMRS PET-CT imaging-only session within 120 minutes of injection over 20-35 minutes.
干预措施: Positron Emission Tomography (Device)
Diagnostic ([18F]-DCFPyL PET-CT, X1 RMRS PET-CT)
Patients receive [18F]-DCFPyL IV and undergo [18F]-DCFPyL PET-CT over 30 minutes per SOC. Patients with PET avid lesions then undergo a X1 RMRS PET-CT imaging-only session within 120 minutes of injection over 20-35 minutes.
干预措施: Computed Tomography (Procedure)
Diagnostic ([18F]-DCFPyL PET-CT, X1 RMRS PET-CT)
Patients receive [18F]-DCFPyL IV and undergo [18F]-DCFPyL PET-CT over 30 minutes per SOC. Patients with PET avid lesions then undergo a X1 RMRS PET-CT imaging-only session within 120 minutes of injection over 20-35 minutes.
干预措施: Fluorine F 18 Piflufolastat (Other)
结局指标
主要结局
Number of Participants With Tumor Visualized on X1 RefleXion Medical Radiotherapy System (RMRS) Positron Emission Tomography-computed Tomography (PET-CT)
时间窗: Up to 72 hours after completion of scan
To determine imaging performance of the X1 PET scan, the number of tumors clearly visualized on PET scan were reported.
Number of Participants With Tumor Visualized on X1 RefleXion Medical Radiotherapy System (RMRS) Positron Emission Tomography-computed Tomography (PET-CT)
时间窗: Up to 72 hours after completion of scan
To determine imaging performance of the X1 PET scan, the number of tumors clearly visualized on PET scan were reported.
次要结局
- Percent of Cases Where X1 RMRS [18F]-DCFPyL PET Data Can be Used to Generate an Acceptable Biology-guided Radiotherapy (BgRT) Plan(Up to 72 hours)
- Percent of Cases Where X1 RMRS [18F]-DCFPyL PET Data Can be Used to Generate an Acceptable Biology-guided Radiotherapy (BgRT) Plan(Up to 72 hours)
