PET/CT Imaging of GRPR Expression in Various Tumors
研究概览
研究类型
注册 (估计的)
阶段
- 第一阶段早期
联系人和位置
学习联系方式
- 姓名:Gad Abikhzer
- 电话号码:514-340-8222
- 邮箱:gad.abikhzer@mcgill.ca
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
描述
Inclusion Criteria:
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
Exclusion Criteria:
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
学习计划
研究是如何设计的?
设计细节
- 主要用途:诊断
- 分配:不适用
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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实验性的:[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.
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[⁶⁸Ga]-LY4257529 is an investigational gastrin-releasing peptide receptor (GRPR)-targeted PET radiopharmaceutical.
Participants will receive approximately 170 MBq ±20% (4.6 mCi ±20%) intravenously.
PET/CT imaging will begin approximately 50-70 minutes after administration to evaluate GRPR-targeted tumor uptake and distribution.
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研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Per-Patient GRPR PET/CT Detection Rate
大体时间:After the PET/CT imaging is completed
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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.
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After the PET/CT imaging is completed
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.