NCT06646952招募中不适用
CD147 Targeting Nanobody Probe for PET Imaging in Solid Tumors
Hua Zhu1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Standardized uptake value（SUV）
研究概览
简要总结
The objective of the study is to construct a noninvasive approach using 68Ga-NOTA-MAL-NB147 PET/CT to detect the CD147 expression of tumor lesions in patients with Solid tumors and to identify patients benefiting from CD147 targeting treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- 否
入选标准
- •Histopathologically or cytologically confirmed malignant melanoma, hepatocellular carcinoma, colorectal cancer, pancreatic cancer, breast cancer, gastric cancer, and lung cancer.
- •Aged ≥18 and ≤75 years, with no gender restrictions.
- •ECOG score of 0 or
- •Expected survival time ≥6 months.
- •At least one easily accessible lesion that can be biopsied within one month before or after the PET scan. The patient consents to using archived or fresh biopsy tissue samples for relevant analysis.
- •Blood routine and liver/kidney function must meet the following criteria: Blood routine: WBC ≥ 4.0×10⁹/L or neutrophils ≥ 1.5×10⁹/L, PLT ≥ 100×10⁹/L, Hb ≥ 90 g/L; PT or APTT ≤ 1.5 ULN; Liver/kidney function: T-Bil ≤ 1.5×ULN (upper limit of normal), ALT/AST ≤ 2.5×ULN or 5×ULN (for subjects with liver metastases), ALP ≤ 2.5×ULN (if bone or liver metastases exist, ALP ≤ 4.5×ULN); BUN ≤ 1.5×ULN; SCr ≤ 1.5×ULN; At least one measurable target lesion according to RECIST 1.1 criteria.
- •Women must use contraceptive measures during the study or for six months after the study ends (effective contraceptive methods include sterilization, hormonal intrauterine devices, condoms, contraceptive pills/devices, abstinence, or partner tubal ligation, etc.). Men must agree to use contraceptive measures during the study or for six months after the study ends.
- •Able to understand and voluntarily sign the informed consent form, with good compliance.
排除标准
- •Pregnant or breastfeeding women, or women planning to become pregnant during the study or within three months after administration, as well as individuals donating sperm or oocytes.
- •Individuals known or suspected to be allergic to the investigational drug or any of its components.
- •Individuals with significantly abnormal liver or kidney function: serum total bilirubin (TBIL) > 1.5 × 20 µmol/L, or aspartate aminotransferase (AST) > 2.5 × 45 µmol/L, or alanine aminotransferase (ALT) > 2.5 × 40 µmol/L, or serum creatinine > 1.5 × 130 µmol/L.
- •Unable to cooperate in completing the PET scan, or suffering from claustrophobia or other conditions that prevent cooperation during the PET scan.
- •Other situations deemed inappropriate for participation in the trial by the investigator. Female patients who are pregnant or breastfeeding.
研究组 & 干预措施
68Ga-NOTA-MAL-NB147
All enrolled participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-NOTA-MAL-NB147 PET/CT scan.
干预措施: 18F-FDG (Drug)
结局指标
主要结局
Standardized uptake value（SUV）
时间窗: 2 years
SUV is a semi-quantitative analysis index to describe the radioactive uptake of lesions, which has certain reference value for differentiating benign and malignant lesions。 The uptake of the tracer （68Ga-NOTA-MAL-NB147） in solid tumor lesions by measuring SUV on PET/CT.
次要结局
未报告次要终点
研究者
Hua Zhu
Principal Investigator
Peking University Cancer Hospital & Institute
研究点 (1)
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