NCT06454955招募中早期 1 期
Study of B7-H3 Mediated Tumor Immune Response Using a Whole-Body Kinetic Approach in Whole-Body PET
Peking University Cancer Hospital & Institute1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年1月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 早期 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- SUV
研究概览
简要总结
Based on [68Ga]B7H3 Affibody-BCH, this study investigates its radioactive uptake and imaging capabilities in tumor patients, with the aim of establishing a correlation between radioactive uptake and B7-H3 receptor expression. Utilizing whole-body PET technology, the pharmacokinetic dynamics of [68Ga]B7H3 Affibody-BCH are examined to ascertain its pharmacological characteristics. Ultimately, this research establishes a framework for pharmacokinetic analysis using whole-body PET.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age range 18-75 years, open to both male and female participants;
- •Participants must meet the following hematologic and hepatic/renal function criteria: Hematology: WBC ≥ 4.0 × 10^9/L or neutrophils ≥ 1.5 × 10^9/L, platelets ≥ 100 × 10^9/L, hemoglobin ≥ 90 g/L; Prothrombin time (PT) or Activated partial thromboplastin time (APTT) ≤ 1.5 times the upper limit of normal (ULN); Hepatic and renal functions: Total bilirubin (T-Bil) ≤ 1.5 times the upper threshold limit (ULT), ALT/AST ≤ 2.5 ULN or ≤ 5 ULT for subjects with liver metastasis, Alkaline phosphatase (ALP) ≤ 2.5 ULN (or ≤ 4.5 ULN in cases of bone or liver metastasis); Blood urea nitrogen (BUN) ≤ 1.5 × ULT, serum creatinine (SCr) ≤ 1.5 × ULT;
- •Normal cardiac function;
- •Expected survival of at least 12 weeks;
- •Good adherence to follow-up;
- •Presence of at least one measurable target lesion according to RECIST 1.1 criteria;
- •Women of childbearing age (15-49 years) must undergo a pregnancy test within seven days prior to the commencement of the study and test negative; sexually active male and female participants must agree to utilize effective contraception to prevent pregnancy during the study and for three months following the final examination;
- •Patients for whom a clinical physician recommends PET/CT scans for the diagnosis and staging of tumors;
- •Participants must fully understand and voluntarily agree to participate in the study, and must sign an informed consent form.
排除标准
- •Severe abnormalities in liver and renal function and blood counts;
- •Patients planning to conceive;
- •Pregnant or lactating women;
- •Individuals unable to lie flat for thirty minutes;
- •Individuals who refuse to participate in this clinical study;
- •Individuals suffering from claustrophobia or other psychiatric disorders;
- •Other situations deemed unsuitable for trial participation by the researchers.
研究组 & 干预措施
Each patient must undergo dynamic PET/CT imaging with [68Ga]B7H3 Affibody-BCH.
Experimental
干预措施: [68Ga] B7H3 Affibody-BCH (Drug)
结局指标
主要结局
SUV
时间窗: 1 hour and 2 hour after injection
Standardized Uptake Values (SUV) of \[68Ga\] B7H3 Affibody-BCH at various time points within the imaging window for target lesions or suspected tumor lesions in subjects with malignant tumors.
次要结局
未报告次要终点
研究者
研究点 (1)
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