Posluma (18F-rhPSMA) PET Guided Radiotherapy Planning in Prostate Cancer: A Prospective Study Evaluating POSLUMA PET Tumor Detection on Radiation Therapy Planning and on BGRT Planning on the RefleXion X1 System
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Comparison of imaging performance of the [18F]-rhPSMA positron emission tomography (PET)-computed tomography (CT) on the X1 RefleXion Medical Radiotherapy System (RMRS)
研究概览
简要总结
This clinical trial evaluates [18F]-rh PSMA positron emission tomography (PET)-computed tomography (CT) imaging performance in patients with prostate cancer. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 18F-rhPSMA. Because some cancers take up [18F]-rhPSMA, cancer cells can be seen with PET. 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. Posluma (18F-rhPSMA) is an approved prostate-specific membrane antigen (PSMA) imaging agent for prostate cancer. The RefleXion Medical Radiotherapy System (RMRS) is designed to facilitate delivery of biology-guided radiotherapy (BgRT). The system uses PET emissions to guide radiotherapy delivery in real-time and has been studied for use with fludeoxyglucose (FDG) (which is an agent used in standard PET-CT scans that targets glucose). Information gathered from this study may help researchers to improve PET-CT imaging on the RefleXion system. This information will be used in the future to improve planning and delivery of radiation therapy that will target (in real time) the signal released from the [18F]-rhPSMA PET-CT tracer. Comparing the imaging from the standard of care [18F]-rh PSMA PET-CT with the imaging from RMRS may help improve the quality of the imaging captured on the RMRS for detection of imaging signals in patients with prostate cancer.
详细描述
PRIMARY OBJECTIVE:
I. To evaluate the imaging performance of flotufolastat F-18 gallium ([18F]-rhPSMA) PET-CT imaging subsystem of the RefleXion Medical Radiotherapy System Device in patients with lesions detected on standard-of-care (SOC) [18F]-rhPSMA PET-CT on the same day.
SECONDARY OBJECTIVES:
I. To evaluate the frequency that SOC Posluma imaging will result in the ability to distinctly identify and separate PET activity from bladder activity to aid in the detection, lesion contouring, RT planning and RT delivery for intra-prostatic lesions, prostate bed lesions (salvage RT) or lesions near the bladder.
II. To evaluate the frequency that SOC Posluma imaging will result in a change in radiotherapy planning through either exclusion due to extra-pelvic metastatic disease or detection of disease that results in a modification of RT field coverage or dose.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Device Feasibility
- 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 with SOC [18F]-RhPSMA PET-CT in whom a PET avid lesion is identified
- •Able to get same day X1 RMRS PET
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
Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT)
Patients receive SOC flotufolastat F-18 gallium IV and undergo PET-CT on study. Patients then undergo X1 RMRS PET-CT imaging-only session 120 minutes post-injection.
干预措施: Computed Tomography (Procedure)
Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT)
Patients receive SOC flotufolastat F-18 gallium IV and undergo PET-CT on study. Patients then undergo X1 RMRS PET-CT imaging-only session 120 minutes post-injection.
干预措施: Flotufolastat F-18 Gallium (Other)
Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT)
Patients receive SOC flotufolastat F-18 gallium IV and undergo PET-CT on study. Patients then undergo X1 RMRS PET-CT imaging-only session 120 minutes post-injection.
干预措施: Medical Device Usage and Evaluation (Other)
Device Feasibility ([18F]-rhPSMA PET-CT, X1 RMRS PET-CT)
Patients receive SOC flotufolastat F-18 gallium IV and undergo PET-CT on study. Patients then undergo X1 RMRS PET-CT imaging-only session 120 minutes post-injection.
干预措施: Positron Emission Tomography (Procedure)
结局指标
主要结局
Comparison of imaging performance of the [18F]-rhPSMA positron emission tomography (PET)-computed tomography (CT) on the X1 RefleXion Medical Radiotherapy System (RMRS)
时间窗: Up to 72 hours after completion of imagining session
Will compare the performance of the \[18F\]-RhPSMA PET-CT subsystem on the RefleXion X1 system to detect selected lesions in patients with prostate cancer with the SOC diagnostic \[18F\]- RhPSMA PET-CT. One key metric will be the percent of patients with lesions identified on SOC PET-CT that are not identified on X1 (false negatives if considering SOC the true standard). With 25 patients with lesions detected by SOC Posluma PET who undergo X1 scanning, there is at least 93% chance of finding a false negative on X1 if the true false negative rate is 10%. With 25 patients, if there are no false negatives, a false negative rate of 11.3% or above can be ruled out with a type I error \<5%. Any discordances will be documented, and the final disposition recorded after a discussion between the radiation oncologist and the nuclear medicine radiologist. Graphical presentations will be provided to compare SOC positive lesions and X1 positive lesions, and SOC positive lesions and X1 neg
次要结局
- Incidence of change in treatment planning based on SOC Posluma(Up to 72 hours after imaging session)
- Percent of cases where X1 RMRS PET data can be used to generate an acceptable biology-guided radiotherapy (BgRT) plan(Up to 72 hours after imaging session)