Non-significant Risk (NSR) Study of [68Ga]-PSMA-11 (Illuccix) as a BgRT BioGuide on the RefleXion X1 System in Patients Already Undergoing Diagnostic PET (Positron Emission Tomography) PSMA (Prostate Specific Membrane Antigen) Imaging
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Qualitative assessment of RefleXion X1 imaging performance with Illuccix PSMA PET imaging agent immediately following a standard of care Illuccix PET/CT
研究概览
简要总结
To qualitatively determine the imaging performance of PET-CT imaging subsystem of the RefleXion X1 System Device in patients undergoing standard-of-care (SOC) [68Ga]-PSMA-11 PET-CT using Illuccix on the same day.
详细描述
In this non-significant risk (NSR) study, investigators will perform imaging only (no treatment) on the X1 platform immediately following an already planned PET/CT diagnostic imaging using Illuccix for standard of care indications in men with prostate cancer of various stages. This approach will be used to assess imaging performance of the X1 in comparison to diagnostic imaging scanners. Evidence from this study will supplement and enhance technical understanding of the PSMA-11-guided BgRT delivery in the setting of prostate cancer. As such, the patient population selected for this investigation is meant to optimally represent the spectrum of cases, with respect to motion and radiographic environment that a radiation oncologist may encounter in practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Men with prostate adenocarcinoma undergoing standard of care PSMA-PET imaging for initial staging or re-staging at suspected relapse/progression
排除标准
- •1. Known psychiatric or substance abuse disorder which in the opinion of the investigator would interfere with study conduct
- •2. Patient weight exceeding 450 lb (weight limit of RefleXion X1 system)
- •3. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that, in the opinion of the investigator, would limit compliance with study requirements.
研究组 & 干预措施
Single group non blinded
Single Center Study, pilot/feasibility, private for profit observational study
干预措施: PET-CT imaging subsystem of the RefleXion X1 System Device (Diagnostic Test)
结局指标
主要结局
Qualitative assessment of RefleXion X1 imaging performance with Illuccix PSMA PET imaging agent immediately following a standard of care Illuccix PET/CT
时间窗: From time of Reflexion scan to 48 hours after scan for adverse event evaluation
Qualitative imaging performance of the PET subsystem on the X1 system for detect PSMA-11 68Ga (Illuccix)-avid lesions (primary and metastatic) in patients with prostate cancer, relative to diagnostic \[68Ga\]-PSMA-11 PET-CT. This will be assessed by the enrolling investigator with the following question: Is there an Illuccix (PSMA-11 Ga68) avid target that correlates to the tumor location on the registered CT image? (Yes/No)
次要结局
未报告次要终点
研究者
Neil Desai
Principal Investigator
University of Texas Southwestern Medical Center