Non-Invasive Detection of Claudin18.2 in Pancreatic and Gastric/Gastroesophageal Junction Cancer by [68Ga]Ga-NODAGA-SNA014 PET Imaging
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Standardized uptake value(SUV)
研究概览
简要总结
The purpose of this study is to use Claudin 18.2 (CLDN18.2)-targeted positron emission tomography (PET) imaging technology to evaluate its detection efficacy and diagnostic threshold for CLDN18.2-positive pancreatic cancer and gastric/gastroesophageal junction cancer, analyze the quantitative value of PET parameters in CLDN18.2 expression and their correlation with prognosis, and provide a basis for the precise selection of CLDN18.2-targeted therapy.
详细描述
The investigators will number all participants, create a medical record file, and record their basic information (gender, age) as well as contact information and medical history information. One or two [68Ga]Ga-NODAGA-SNA014 PET scans will be performed according to disease stage and treatment plan. CLDN18.2 expression will be assessed by immunohistochemistry (IHC) in surgical specimens. The optimal SUV threshold and PET quantification potential for CLDN18.2 expression will be evaluated in comparison with histopathology, along with their correlation with prognosis.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 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
- •Participants with histopathologically confirmed pancreatic cancer and gastric/gastroesophageal junction cancer with claudin 18.2 expression of any level, including treatment-naive patients with upfront resectable disease, patients with post-operative recurrent disease who are or become resectable following treatment, and patients rendered resectable after neoadjuvant or conversion therapy.
- •Signed and dated informed consent form.
- •Commitment to comply with research procedures and co-operation in the implementation of the full research process.
- •Male or female participants.
- •Aged 18-75 years old.
- •Good general performance status with an expected overall survival of more than 6 months.
排除标准
- •Participants with prior Claudin 18.2 targeted therapy.
- •Participants with concurrent other active malignancies.
- •Participants with severe medical conditions that render them unsuitable for participation in this clinical study. Such as severe heart and lung failure, severe bone marrow suppression, severe liver and kidney dysfunction, etc.
- •Pregnant women and women who may be pregnant, women who are breastfeeding.
- •Participants with poor compliance.
研究组 & 干预措施
participants with pancreatic cancer, gastric cancer or GEJ cancer and CLDN18.2 expression
Participants with pancreatic cancer, gastric cancer or gastroesophageal junction (GEJ) cancer and immunohistochemistry (IHC)-confirmed CLDN18.2 expression at any level.
结局指标
主要结局
Standardized uptake value(SUV)
时间窗: Baseline and preoperative assessment at 3 weeks before surgery
Participants include treatment-naive patients with upfront resectable disease, those becoming resectable after neoadjuvant or conversion therapy, and patients with recurrent disease that is either resectable or becomes resectable following treatment. One or two \[68Ga\]Ga-NODAGA-SNA014 positron emission tomography (PET) scans will be performed according to disease stage and treatment strategy, with claudin18.2 immunohistochemistry to be conducted on surgical specimens. Upfront resectable patients will undergo one preoperative scan, while patients requiring treatment prior to resection will receive one scan before treatment and an additional scan before surgery. The SUV values of tumor lesions will be measured on PET images.
The expression level of Claudin-18.2
时间窗: Baseline and intraoperative specimen collection, assessment within 3 weeks postoperatively
Histopathologically confirmed pancreatic cancer or gastric/gastroesophageal junction cancer with any level of claudin 18.2 expression confirmed by immunohistochemistry (IHC) before enrollment. Claudin 18.2 expression will be further analyzed by IHC in surgical specimens.
次要结局
- Progress free survival(3 years)
- Overall survival(3 years)