PET/CT Imaging of GRPR Expression in Various Tumors
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 60
- 主要终点
- Per-Patient GRPR PET/CT Detection Rate
研究概览
简要总结
This open-label imaging study will evaluate [⁶⁸Ga]-LY4257529 PET/CT, a gastrin-releasing peptide receptor (GRPR)-targeted radiopharmaceutical, in patients with cancers known or suspected to express GRPR. Up to 60 participants will be enrolled in two cohorts: 30 patients with breast cancer and 30 patients with other selected malignancies, including prostate, ovarian, pancreatic, small-cell lung, head and neck squamous cell carcinoma, and other tumors with documented GRPR expression.
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
- •Age 18 years or older Able to understand and provide written informed consent
- •Diagnosis of a breast cancer or other tumor known or suspected to express GRPR, including:
- •ER-positive/HER2-negative breast cancer Invasive lobular breast cancer Head and neck squamous cell carcinoma Small-cell lung cancer Ovarian cancer Prostate cancer with biochemical recurrence and a negative PSMA PET/CT Metastatic pancreatic cancer after pancreatic surgery Other tumor with GRPR expression demonstrated on histopathology ECOG performance status 0-3 Under the care of a referring physician Able to tolerate PET/CT imaging, including lying supine for up to 30 minutes with arms above the head and intravenous cannulation
排除标准
- •Tumor type known in the literature not to express GRPR, unless patient-specific tissue demonstrates GRPR expression Medically unstable condition, including acute cardiac or respiratory distress or hypotension Weight exceeding PET/CT table limit of 200 kg or inability to fit within the 70-cm PET/CT bore Unmanageable claustrophobia Known allergic or hypersensitivity reaction to a prior GRPR-targeting radioligand such as ⁶⁸Ga-RM2 or bombesin analogues Pregnancy Lactation For individuals of childbearing potential, inability to document a negative pregnancy test before tracer administration
研究组 & 干预措施
[⁶⁸Ga]-GRPR PET/CT
Participants with breast cancer or other selected GRPR-expressing malignancies will receive a single intravenous administration of approximately 170 MBq ±20% of [⁶⁸Ga]-LY4257529, followed by PET/CT imaging approximately 50-70 minutes after injection. All participants undergo the same imaging intervention.
干预措施: GRPR PET/CT (Diagnostic Test)
结局指标
主要结局
Per-Patient GRPR PET/CT Detection Rate
时间窗: After the PET/CT imaging is completed
Proportion of participants with at least one GRPR-positive lesion on \[⁶⁸Ga\]-LY4257529 PET/CT. Detection rate will be calculated as the number of participants with at least one GRPR-positive lesion divided by the total number of participants in the relevant cancer cohort.
次要结局
未报告次要终点