NCT06906471招募中1 期
A Single-Arm, Blinded, Fluorescent PSMA Histopathology Trial of AS1986NS
Antelope Surgical Solutions, Inc3 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2026年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 10
- 试验地点
- 3
- 主要终点
- Safety of AS1986NS
研究概览
简要总结
A Single-Arm, blinded, fluorescent PSMA histopathology trial of AS1986NS
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 90 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •suspected prostate cancer warranting standard of care multi-core prostate biopsy
排除标准
- •Patients receiving same-day therapeutic Lutetium-177 or Actinium-225 PSMA receptor radiation isotope therapy treatment
- •Patients with pre-existing, impaired or abnormal hepatic function, renal function, cardiac function, and abnormal elevated temperature
- •Patients with a creatinine clearance cutoff (CrCl) of < 60 mL/min
研究组 & 干预措施
Single dose of AS1986NS
Experimental
Single dose of AS1986NS administered as an injection through peripheral intravenous access.
干预措施: AS1986NS (Drug)
结局指标
主要结局
Safety of AS1986NS
时间窗: Enrollment to 30 days post single infusion
Demonstrate that AS1986NS is 'safe' as a microdosed \<100 µg, \<100 µL, 1 mg/mL per patient dose when introduced intravenously as a bolus through peripheral intravenous access by evaluation of the Adverse Events (AEs), including Serious Adverse Events (SAEs), that occur in patients treated with AS1986NS
次要结局
未报告次要终点
研究者
研究点 (3)
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