Total Body PET-CT Imaging of Prostate Cancer Using Illuccix (Kit for the Preparation of Ga-68 PSMA-11 Injection)
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- BAMF Health
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Comparing the imaging quality using low dose and high dose Ga-68 PSMA-11 at various scan lengths.
研究概览
简要总结
Illuccix will be used per the prescribing instructions for PET-CT imaging on the United Imaging scanner uEXPLORER to establish a standard scanning protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Provision of signed and dated informed consent form
- •Male ≥ 18 years of age
- •Patients meeting clinical need for Illuccix PET scan:
- •Patients with suspected metastasis who are candidates for initial definitive therapy
- •Patients with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level
- •Patient is physically able to lay flat for the PET-CT procedure
排除标准
- •Assessment by the Investigator as unable or unwilling to comply with the requirements of the protocol.
研究组 & 干预措施
Low Dose
3 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time.
干预措施: illuccix 68Ga-PSMA-11 Total Body PET-CT (Drug)
High dose
7 mCi dose of 68Ga-PSMA-11 (Illuccix) and a total body PET-CT scan for 4-6 min scan time.
干预措施: illuccix 68Ga-PSMA-11 Total Body PET-CT (Drug)
结局指标
主要结局
Comparing the imaging quality using low dose and high dose Ga-68 PSMA-11 at various scan lengths.
时间窗: 3 months
In modulating the dose and scan time, including reconstitution of the images, we will identify optimal protocol for use of Illuccix on total body PET/CT through evaluation of image quality at variable dose and scan length.
次要结局
未报告次要终点