A Phase 1 Study of [18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Incidence of study drug emergent adverse events
研究概览
简要总结
The study is an open label, single-arm study designed to evaluate the safety and diagnostic performance of [18F]FLOR (FC303) PET/CT imaging to determine the presence or absence of metastatic prostate cancer. .
详细描述
This research is being done to determine whether the radioactive compound called [18F]FLOR (FC303) is safe and well-tolerated in patients with metastatic prostate cancer.
Participants in this study will have tests, exams and procedures that are for study purposes. Participants will be in this study up to one month which will include up to three clinic visits.
Eligible patients diagnosed with metastatic prostate cancer will undergo a [18F]FLOR (FC303) PET-CT scan. This is the imaging procedure to assess where [18F]FLOR (FC303) has accumulated in the body.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Males ≥18 years of age.
- •Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
- •Histologically confirmed adenocarcinoma of the prostate.
- •Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, or MRI), or whole-body bone scan within 4 weeks of Day
- •At least 2 weeks must have elapsed between last anti-cancer treatment administration and the imaging day. Imaging day will be scheduled before initiation of new systemic therapy for recurrent and/or progressive metastatic disease
- •Screening clinical laboratory values within normal limits or judged not clinically significant by the investigator.
排除标准
- •Subjects administered any radioisotope within five physical half-lives prior to study drug injection.
- •Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
研究组 & 干预措施
[18F]FLOR (FC303)
[18F]FLOR (FC303) PET/CT imaging.
干预措施: [18F]FLOR (FC303) Injection (Drug)
结局指标
主要结局
Incidence of study drug emergent adverse events
时间窗: Up to 10 days post-study drug dosing
Incidence of study drug emergent adverse events will be assessed.
次要结局
未报告次要终点