NCT07062549招募中1 期
First-in-Human Study of 111In-XYIMSR-01 SPECT/CT in Patients With Metastatic Clear Cell Renal Cell Carcinoma
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2022年1月26日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Number of adverse events
研究概览
简要总结
This study is being done to determine if the investigational radiotracer called 111In-XYIMSR-01 is helpful in detecting clear cell renal cell carcinoma tissue in your body when used during a SPECT-CT Scan
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
- 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
- •Males or female sex
- •≥18 years of age
- •Willingness to provide signed informed consent and comply with all protocol requirements
- •Histological confirmation of RCC with a clear cell component
- •2-10 sites of disease measuring ≥1.5 cm on contrast-enhanced CT and/or MRI imaging of the chest, abdomen and pelvis performed ≤60 days prior to the date of study enrollment
- •Screening clinical laboratory values as specified below:
- •Serum bilirubin ≤ 1.5 times the upper limit of normal; for patients with known Gilbert's syndrome, ≤ 3 × ULN is permitted
- •ALT ≤ 3 times the upper limits of normal
- •AST ≤ 3 times the upper limits of normal
- •Creatinine clearance ≥50 mL/min based on Cockcroft-Gault formula
- •Absolute neutrophil count ≥ 1,500 /mm3
- •Platelets ≥100,000/ mm3
- •Hemoglobin ≥ 9.0 g/dL
- •White blood cell count ≥ 2,000/ mm3
排除标准
- •Systemic therapy for the treatment of ccRCC within 12 months of study enrollment.
- •Subjects administered any radioisotope within five physical half-lives prior to study drug injection.
- •Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.
- •Women of child-bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU/L or equivalent units of human chorionic gonadotropin) within 24 hours prior to the imaging day.
- •Women must not be breastfeeding.
研究组 & 干预措施
A (111In-XYIMSR-01)
Experimental
Participants who receive 111In-XYIMSR-01 dosing and SPECT/CT imaging
干预措施: 111In-XYIMSR-01 (Drug)
结局指标
主要结局
Number of adverse events
时间窗: From enrollment to the end of treatment at 1 week
To evaluate the safety, tolerability, and feasibility of SPECT/CT imaging with 111In-XYIMSR-01 measured by all adverse events according to CTCAE version 5.
次要结局
- Number of lesions detected(From enrollment to the end of treatment at 1 week)
- Biodistribution assessed by SPECT/CT images(From enrollment to the end of treatment at 1 week)
- Radiation Dosimetry assessed by SPECT/CT images(From enrollment to the end of treatment at 1 week)
- Total Radioactivity Concentration of 111In-XYIMSR-01 in Plasma Over Time(From enrollment to the end of treatment at 1 week)
研究者
研究点 (1)
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