Monocentric Observational Study on the Diagnostic and Prognostic Role of 18F-PSMA PET (PET/CT and PET/MR) in Prostate Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,500
- 试验地点
- 1
- 主要终点
- PET with 18F-PSMA for diagnostic accuracy for staging of prostate cancer.
研究概览
简要总结
The general objective of this retrospective and prospective study is to evaluate the diagnostic and prognostic role of a quantitative analysis of PET images with 18F-PSMA in all stages of the disease in patients with prostate cancer. To this end, both imaging parameters commonly used in clinical practice and the contribution of radiomic features will be investigated. The latter are quantitative features extracted from biomedical images, and are believed to be able to provide information, otherwise impossible to investigate, useful for the characterization of various pathologies. This methodology is very promising, but also recent and therefore little studied and standardized. Our objective is also to investigate how to optimize it from a purely methodological point of view.
详细描述
In this study, all PET images with 18F-PSMA will be considered, but also the CT or MR images associated with them to allow better anatomical localization.
This study will allow us to investigate the diagnostic and prognostic role of l8F-PSMA PET, also evaluating its predictive value in terms of disease course, development of metastases and mortality. The retrospective part of this protocol is necessary for the acquisition of a sufficiently large amount of data to guarantee adequate statistical power for the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •adult male patients;
- •patients with histopathological diagnosis of prostate cancer undergoing staging or restaging;
- •patients with clinical indication for PET examination with 18 F-PSMA;
排除标准
- •medical conditions that do not allow the acquisition of PET images;
- •allergic reactions to iodinated contrast medium or creatinine levels >2mg/dL.
结局指标
主要结局
PET with 18F-PSMA for diagnostic accuracy for staging of prostate cancer.
时间窗: 5 years
the role of a quantitative-semi-quantitative analysis for the characterization of prostatic pathology in different phases of the disease.
次要结局
未报告次要终点
研究者
Chiti Arturo
Professor in Diagnostic Imaging and Radiotherapy Faculty of Medicine and Surgery, Vita-Salute San Raffaele University Director, Department of Nuclear Medicine, IRCCS Ospedale San Raffaele
IRCCS San Raffaele