NCT06209567进行中（未招募）早期 1 期
An Investigator-Initiated Study to Evaluate PSMA Expression in Patients With High-Grade Gliomas or Brain Metastases With 68Ga-PSMA-11 PET
适应症
试验速览
- 阶段
- 早期 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 11
- 试验地点
- 14
- 主要终点
- Assess range of tumor uptake of 68Ga-PSMA-11 in participants
研究概览
简要总结
The purpose of this study is to find out whether 68Ga-PSMA-11 PET/CT is effective in assessing tumor uptake (tumor activity seen in cancerous tissue) in participants with high-grade glioma/HGG or brain metastases.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Ability to understand and the willingness to sign (or their legally acceptable representative (LAR) must sign) a written informed consent document
- •Adults ≥ 18 years old
- •Suspicion for or histologically or cytologically confirmed and previously treated HGG or brain metastases from a primary extracranial malignancy
- •Lesion size ≥ 1 cm (for the lesion to be biopsied)
- •ECOG performance status ≤ 2 (Karnofsky ≥ 60%)
- •Planned to undergo biopsy/resection of brain lesion
排除标准
- •Inability to undergo a PET scan (e.g., claustrophobia or noncompatible implant in case PET/MR is performed)
- •Pregnant or nursing female. All women of childbearing potential must have a documented negative serum or urine pregnancy test <1 week before study.
- •Uncontrolled, intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiacarrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- •Patients with severe allergy to both iodinated and gadolinium contrast.
结局指标
主要结局
Assess range of tumor uptake of 68Ga-PSMA-11 in participants
时间窗: up to 12 months
Intensity and range of tumor uptake of 68Ga-PSMA-11 will be described using the SUVmean and SUVmax
次要结局
未报告次要终点
研究者
研究点 (14)
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