NCT07169825招募中4 期
Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA in Patients With Compromised Renal and/or Bone Marrow Function
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- safety and adverse events (AEs).
研究概览
简要总结
To determine the dose of Pluvicto therapy absorbed in the tumors and organs of patients whose kidneys and/or bone marrow are not working properly.
详细描述
Primary Objectives
• To determine the personalized radiation dose to tumors and critical organs of participants with compromised renal and / or bone marrow function.
Secondary Objectives
- To compare target radiation doses based on varying SPECT scan duration. Plot the variability in target radiation dose versus scan duration.
- To compare the image quality and dosimetry results when considering the low, high, and both energy peaks of Lu-177.
- To compare target radiation doses based on multiple imaging time points versus a single time point and identify which time point is most suited for this evaluation.
- To compare target radiation doses derived from organ versus voxel dosimetry calculation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria
- •Participants that are approved for Pluvicto therapy and have been identified to have renal complications or compromised marrow function. Renal complication is defined as GFR: 30-50ml/min, creatinine: ULN-twofold ULN; while compromised marrow function is indicated by total WBC 2.5 x 109 L - LLN, or platelet count 75-100 x 109 L.
- •Participants who agree to be imaged multiple times as defined in the study protocol.
排除标准
- •Pluvicto therapy patients without renal or marrow function complications
- •Participants who do not wish to be imaged multiple times as per the study protocol.
- •Women and children since this is treatment for prostate cancer.
研究组 & 干预措施
Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA
Experimental
干预措施: SPECT (Other)
Evaluation of Targeted Radionuclide Therapy of Lu-177 PSMA
Experimental
干预措施: Lu-177 (Drug)
结局指标
主要结局
safety and adverse events (AEs).
时间窗: Through study completion; an average of 1 year
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
次要结局
未报告次要终点
研究者
研究点 (1)
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