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临床试验/NCT06429891
NCT06429891招募中不适用

Research on Early Diagnosis and Clinical Transformation of Nuclide Probe Based on Bioorthogonal-gastric Cancer Mucin Target Visualization

Hua Zhu1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2024年8月20日最近更新:
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
50
试验地点
1
主要终点
Standardized uptake value (SUV)

研究概览

简要总结

The symptoms of early gastric cancer are extremely insidious and most patients are identified as advanced at the time of initial diagnosis. Starting from the clinical needs, this project selects solid tumors and pathogenic glycoprotein synthesis of key glycopeptide antigen determinant mucin (MUC) family of multiple molecules as the research object. Based on the digestive system tumor research cohort established in the early stage, this project intends to verify the tumor microenvironment characteristics of the MUC family and gastric cancer treatment resistance through immunohistochemistry, COSMC gene sequencing and other technologies, and screen key MUC family proteins. Based on the discovery of differential recognition of COSMC deficient cells by antibodies, MUC1-targeted specific monoclonal antibody was developed. Further development of spatial mucinomics based on laser ablation inductively coupled plasma mass spectrometry (LA-IPC-MS) and spatial metabolome based on desorption electrospray mass spectrometry (DESI-MS) to analyze the structure and immunosuppressive mechanism of key gastric cancer glycoprotein MUC. After obtaining key targeted antibodies, with the help of biological orthogonal and click chemistry technology, the original clinical translational research based on mucin targeting was carried out, and a high-affinity nuclide conjugate drug (RDC) with "triple binding" of gastric cancer mucin was constructed and clinical translational research was carried out, which provided new ideas for the accurate diagnosis and treatment of gastric cancer in the early stage.

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Aged ≥18 years old; ECOG 0 or 1;
  • Patients with solid tumor confirmed by histopathology;
  • Patients with imaging confirmed measurable lesions;
  • life expectancy >=12 weeks.

排除标准

  • Significant hepatic or renal dysfunction;
  • ls pregnant or ready to pregnant;
  • Cannot keep their states for half an hour;
  • Refusal to join the clinical study;
  • Suffering from claustrophobia or other mental diseases;
  • Any other situation that researchers think it is not suitable to participate in the experiment.

研究组 & 干预措施

89Zr-16A

Experimental

All study participants will be allocated to this arm (single-arm study). Study participants will undergo 89Zr-16A PET/CT scans.

干预措施: 18F-FDG (Drug)

结局指标

主要结局

Standardized uptake value (SUV)

时间窗: 2 years

The uptake of the tracer (89Zr-16A) in solid tumor lesions or suspected tumor lesions by measuring SUV on PET/CT.

次要结局

未报告次要终点

研究者

发起方
Hua Zhu
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Hua Zhu

Principal Investigator

Peking University Cancer Hospital & Institute

研究点 (1)

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