MMP14(MT1-MMP) Targeting Bicyclic Peptide Probe for PET 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
- 30
- 试验地点
- 2
- 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-labeled bicyclic peptide radiotracer to detect the matrix metalloproteinase 14 (MMP14, MT1-MMP) expression of tumor lesions in patients with solid tumors and to identify patients benefiting from MMP14 targeting treatment.
详细描述
Analysis plan: 1. Recruit 3-5 participants to analyze preliminary pharmacokinetic/first-in-human dose (FIH), major organ distribution, and tumor uptake information via whole-body PET/CT imaging; 2. Recruit 20-30 participants to analyze in vivo safety and tumor targeting information; 3. Recruit all participants for a final summary.
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
- •Malignant melanoma, glioma, lung cancer, colon cancer, pancreatic cancer, gastric cancer, breast cancer, liver cancer, etc., confirmed by histopathology or cytology;
- •age ≥18 and ≤75 years old, male or female;
- •ECOG score 0 or 1;
- •expected survival time ≥6 months;
- •There was at least one measurable target lesion according to RECIST1.1 criteria, and biopsy could be performed within one month before and after PET scan, and the patient could provide 2-3 lesion tissue slides;
- •Women of childbearing age (15-49 years) must have had a negative pregnancy test within 7 days before starting testing; Women and men of childbearing potential must agree to use effective contraception to avoid pregnancy during the study and for 3 months after the examination;
- •patients recommended by clinicians to undergo PET/CT examination for tumor staging;
- •The subjects could fully understand and voluntarily participate in this experiment, and signed an informed consent.
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-MMP14
All enrolled participants will be allocated to this arm (single-arm study). Study participants will undergo 68Ga-MMP14 PET/CT scan.
干预措施: 18-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-MMP14） in solid tumor lesions by measuring SUV on PET/CT.
次要结局
未报告次要终点