Comparison of the Diagnostic Efficacy of [68Ga]Ga-CTR-FAPI PET/MRI and 18F-FDG PET/MRI for Lymph Node Metastasis in Middle to High Rectal Cancer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 主要终点
- Sensitivity and Specificity of Lymph Node Metastasis Detection
研究概览
简要总结
This is a prospective, single-center, diagnostic study designed to compare the accuracy of [68Ga]Ga-CTR-FAPI PET/MRI and [18]F-FDG PET/MRI for the detection of lymph node metastasis in patients with initially untreated, resectable middle to high rectal cancer. The study aims to evaluate whether [68Ga]Ga-CTR-FAPI PET/MRI provides higher sensitivity and specificity than traditional 18F-FDG PET/MRI at both the patient level and the lymph node level.
详细描述
Accurate preoperative staging of colorectal cancer is crucial for formulating treatment plans and improving patient prognosis. While conventional MRI and 18F-FDG PET/MRI are utilized, they face limitations such as false positives due to inflammatory lymph nodes or fibrotic scars. Fibroblast activating protein inhibitor (FAPI) specifically targets tumor-associated fibroblasts, potentially reducing false-positive rates by avoiding non-specific uptake in inflammatory areas.
This study aims to cross-validate the diagnostic efficacy of these two probes through a precise imaging-pathology matching technique. All enrolled patients will sequentially undergo both [68Ga]Ga-CTR-FAPI PET/MRI and 18F-FDG PET/MRI within 30 days prior to radical surgery. Following surgery, fresh mesorectal specimens will be precisely sectioned and matched to preoperative anatomical imaging maps. By leveraging a well-established node-by-node matching and identification methodology with high accuracy, this study ensures the execution of spatial correlation between preoperative radiologic imaging and postoperative microscopic pathology. Through mapping individual lymph nodes, the study will analyze the root causes of false positives and negatives, and extract radiomics features to evaluate their correlation with the tumor microenvironment (e.g., fibroblast density, Ki-67 index).
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed rectal adenocarcinoma by pathological biopsy.
- •Lower margin of the tumor is ≥ 5 cm and ≤15 cm from the anal verge.
- •Planned to undergo radical surgery.
- •ECOG performance status score ≤
- •Patient is willing to undergo PET/MRI examination.
排除标准
- •History of pelvic radiotherapy or chemotherapy.
- •Concurrent with other malignant tumors or active infections.
- •Pregnant or unable to sign the informed consent form.
- •Claustrophobia or inability to tolerate MRI examinations due to other reasons.
研究组 & 干预措施
Rectal Cancer Patients
Patients with confirmed middle to high rectal adenocarcinoma who are scheduled for radical surgery.
干预措施: PET/MRI with 18F-FDG and [68Ga]Ga-CTR-FAPI (Diagnostic Test)
结局指标
主要结局
Sensitivity and Specificity of Lymph Node Metastasis Detection
时间窗: Up to 30 days post-surgery
Comparison of the sensitivity and specificity of \[68Ga\]Ga-CTR-FAPI and 18F-FDG PET/MRI in determining lymph node metastasis at both the individual lymph node level and the patient level. Sensitivity is defined as the proportion of imaging-positive and pathology-positive nodes out of all pathology-positive nodes. Specificity is defined as the proportion of imaging-negative and pathology-negative nodes out of all pathology-negative nodes.
次要结局
- False Positive and False Negative Rates(Up to 30 days post-surgery)
- Correlation Between Radiomics Features and Tumor Microenvironment(Up to 30 days post-surgery)