A Retrospective Observational Study Investigating the Safety and Effectiveness of Fluciclovine (18F) (FACBC) PET Ligand in Human Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 714
- 试验地点
- 4
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
研究概览
简要总结
This retrospective observational multi centered study has been established to collect the clinical experience relating to the administration of Fluciclovine 18F employed in both investigator initiated studies and named patient/compassionate use programmes in up to 5 sites.
详细描述
This study will collect clinical data from consenting patients (unless a HIPAA waiver or equivalent was granted) who received the PET radiotracer Fluciclovine 18F (FACBC) (a synthetic amino acid analog) for imaging of patients with various cancers at participating sites in the US and Europe.
Data collection will cover baseline medical history and medications in all patients.
The result of PET radiotracer and other imaging findings, and reports of histopathology from biopsied tissue (where available) and in a time window relevant to the use of PET imaging in the diagnosis of primary/recurrent prostate cancer will be recorded.
In all subjects, with regards to safety monitoring, available data for physical examination, vital signs and laboratory test results will be collected from 28 days prior to and out to a 35 day window after Fluciclovine 18F (FACBC) administration.
The major goals of the investigation are to consolidate the safety profile of Fluciclovine 18F (FACBC), to evaluate its use in the detection of local and extraprostatic recurrence of prostate cancer and to evaluate its ability to detect malignancy in patients undergoing screening for primary prostate cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient managed by a site at which ethical committee approval for retrospective data collection under this protocol has been received
- •Patient has received at least one injection of fluciclovine (18F) for the detection of a malignant tumour at any location
排除标准
- •Subjects will be excluded from the analyses if any of the following criteria are met:
- •Patients participating in clinical trials or open access programmes at countries or sites not participating in this study.
- •Patients managed at sites without ethical committee approval for retrospective data collection under this protocol.
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events and Treatment-Emergent Serious Adverse Events
时间窗: Up to 35 days post Fluciclovine 18F
Treatment-emergent Adverse Events and Treatment-Emergent Serious Adverse Events
Positive Predictive Value of FACBC Compared to Histology to Detect Recurrence in Patients Previously Diagnosed With Prostate Cancer
时间窗: Up to 1 year post Fluciclovine 18F
Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy.
Positive Predictive Value of FACBC to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer
时间窗: Up to 1 year post Fluciclovine 18F
Positive Predictive Value is the percentage of participants with a positive Fluciclovine 18F scan who truly have positive finding in biopsy.
次要结局
- Detection Rate, Sensitivity, Specificity, and Negative Predictive Value in Biochemically Recurrent Prostate Cancer(Up to 1 year post Fluciclovine 18F)
- Detection Rate, Sensitivity, Specificity, and Negative Predictive Value to Detect Presence of Malignant Disease in Patients Undergoing Screening for Primary Prostate Cancer(Up to 1 year post Fluciclovine 18F)