Clinical Application of 89Zr-s-C1 PET/CT Imaging in Solid Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- To evaluate the diagnostic and staging accuracy of ⁸⁹Zr-s-C1 PET/CT imaging in patients with MUC18-positive solid tumors, particularly for lesions that remain indeterminate with conventional imaging modalities or ¹⁸F-FDG PET/CT.
研究概览
简要总结
This project is driven by clinical needs and focuses on the mucin (MUC) family, key glycopeptide antigens involved in mediating immune evasion in solid tumors. We selected multiple members of this family as research subjects. Based on the MUC18 target, we developed the probe ⁸⁹Zr-SS-CNB001 (HuAA98-14, hereafter referred to as ⁸⁹Zr-s-C1). Studies have demonstrated that ⁸⁹Zr-s-C1 PET/CT enables noninvasive in vivo identification of tumor lesions in patients with solid tumors, and its imaging efficacy positively correlates with MUC18 expression levels in the patient's tumor tissue.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Case inclusion criteria
- •Patients with pathologically confirmed newly diagnosed solid tumors (such as melanoma, gastric cancer, colorectal cancer, etc.), or those with recent recurrence or suspected recurrence of previous solid tumors. Both male and female patients are eligible.
- •Hematology, liver, and kidney function meeting the following criteria:
- •Hematology: WBC ≥ 4.0×10⁹/L or neutrophil count ≥ 1.5×10⁹/L, PLT ≥ 100×10⁹/L, Hb ≥ 90 g/L; PT or APTT ≤ 1.5 × ULN.
- •Liver and kidney function: T-Bil ≤ 1.5 × ULN, ALT and AST ≤ 2.5 × ULN (or ≤ 5 × ULN for subjects with liver metastases), ALP ≤ 2.5 × ULN (if bone or liver metastases are present, ALP ≤ 4.5 × ULN); BUN ≤ 1.5 × ULN, SCr ≤ 1.5 × ULN.
- •Expected survival ≥ 12 weeks.
- •Good compliance with follow-up.
- •Presence of at least one measurable target lesion according to RECIST 1.1 criteria.
- •Female subjects must use effective contraception (effective contraception refers to sterilization, intrauterine hormone devices, condoms, contraceptive pills/agents, abstinence, or vasectomized partner) during the study and for 6 months after the study ends; male subjects must agree to use contraception during the study and for 6 months after the study ends.
- •Subjects must fully understand and voluntarily participate in this trial, and sign the Informed Consent Form.
排除标准
- •Severe liver and kidney dysfunction.
- •Women preparing for pregnancy, pregnant, or breastfeeding.
- •Inability to lie flat for half an hour.
- •Inability to provide informed consent.
- •Suffering from claustrophobia or other psychiatric disorders.
- •Known allergy to the investigational drug or its excipients.
- •Other situations deemed unsuitable for trial participation by the researchers.
研究组 & 干预措施
solid tumor
diagnosed solid tumor
结局指标
主要结局
To evaluate the diagnostic and staging accuracy of ⁸⁹Zr-s-C1 PET/CT imaging in patients with MUC18-positive solid tumors, particularly for lesions that remain indeterminate with conventional imaging modalities or ¹⁸F-FDG PET/CT.
时间窗: Imaging and analysis were performed 2, 24, and 48 hours after drug injection
SUVmax and SUVmean
Measure the maximum standardized uptake value (SUVmax) of tumor lesions and compare it with that of surrounding normal tissues (such as the liver and muscles) to calculate the tumor-to-background ratio (TBR).
时间窗: Imaging and analysis were performed 2, 24, and 48 hours after drug injection
SUVmax and SUVmean
次要结局
未报告次要终点
研究者
Hua Zhu
Professor
Peking University Cancer Hospital & Institute