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临床试验/NCT05937919
NCT05937919招募中早期 1 期

CLDN18.2 Targeted 68Ga-PMD22 PET Imaging in Patients With Gastrointestinal Tumours

Peking Union Medical College Hospital1 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2023年5月28日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
招募中
入组人数
10
试验地点
1
主要终点
Dosimetric distribution of radiopharmaceuticals

研究概览

简要总结

To investigate the ability of the CLDN18.2-targeted 68Ga-PMD22 tracer to detect CLDN18.2 expression in patients with gastric and colorectal cancer and other gastrointestinal tumours.

详细描述

The 2016 FAST study brought a "new star" target for gastric cancer - CLDN18.2 (claudin 18 splice variant 2,CLDN18.2), which belongs to the CLDN family of tight junction proteins and is involved in the formation of paracellular tight junctions and maintenance of cell polarity. CLDN18.2 is mainly found in the normal gastric mucosa (normal gastric glands, principal cells, mural cells, endocrine cells) where the differentiation cycle is short and renewal is rapid, and in the duodenal panniculocytes, but not in the gastric stem cell region. It is now generally accepted that CLDN18.2 is expressed in normal gastric tissue confined to the tight junctions at the outer base of the gastric mucosal cells, whereas tumours undergo a change in cell polarity during malignant transformation, resulting in widespread exposure of CLDN18.2 to the cell membrane surface. The CLDN18.2 gene is also aberrantly activated and highly specific and stably expressed in specific tumour tissues, participating in the proliferation, differentiation and migration of tumour cells, making it a potentially effective target for anti-tumour drugs.

In this study, a molecular probe PMD22 targeting CLDN18.2 was synthesised in a previous study and a 68Ga-PMD22 injection was developed for clinical trials. The preliminary study showed that the tracer has good safety and good imaging effect. It is proposed to further conduct exploratory PET/CT imaging studies on patients with gastric cancer, colorectal cancer and other gastrointestinal tumours, to provide a new technique for in vivo, non-invasive and visual detection of CLDN18.2 expression level and spatial distribution for patients with gastric cancer, colorectal cancer and other gastrointestinal tumours, and to validate its clinical application value for the diagnosis of gastric cancer, colorectal cancer and other gastrointestinal tumours.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
— 至 80 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • In the near future (within 2 months), patients who plan to undergo puncture biopsy or undergo tumor surgical treatment or are clinically highly suspected of cancer (including primary and tumor recurrence and metastasis)
  • Able to understand and voluntarily sign informed consent forms, with good compliance

排除标准

  • Severe abnormalities in liver and kidney function
  • Suffering from claustrophobia or other mental illnesses
  • Pregnant and lactating women

研究组 & 干预措施

68Ga-PMD22 PET/CT dynamic scan

Experimental

68Ga-PMD22 PET/CT scan Dosimetry study about 6 patients were injected with 2-4 (MBq) per kilogram body weight of 68Ga-PMD22 PET/CT in one dose intravenously and underwent wholebody scan at 5min#15min#30min#60min#90min#120min#180min, then analysis of dosimetric distribution of radiopharmaceuticals in human body by HERMES software.

干预措施: Intravenous injection of 68Ga-PMD22 (Drug)

68Ga-PMD22 PET/CT scan at one time

Experimental

After the dynamic scan completed, choose an optimal imaging examination time for PET examination of other patients.

干预措施: Intravenous injection of 68Ga-PMD22 (Drug)

结局指标

主要结局

Dosimetric distribution of radiopharmaceuticals

时间窗: 2 months

Input the 68Ga-PMD22 PET data of 5-6 patients into HERMES software, and analyze the dose distribution of radioactive drugs in human body through HERMES software

Standardized uptake value

时间窗: 2 months

The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in breast tumor will be measured. SUV were obtained by a self-made software and referring to phantom study.If the SUV value cannot be obtained, the COUNTS of target organ/background ratio between the lesion and surrounding tissues shall be used for calculation.

次要结局

  • Number of participants with drug-related adverse events(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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