Research Focused on Developing and Assessing a Non-intrusive Diagnostic Approach for Grading Tumor Regression Post-neoadjuvant Treatment in Rectal Cancer, Utilizing 18F-FAPI in Conjunction With FDG PET/MR Imaging.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Evaluation efficacy of tumor regression level
研究概览
简要总结
This project aims to evaluate the role of 18F-FAPI combined with 18F-FDG PET/MRI imaging in quantitatively and accurately evaluating the grading of rectal cancer after SCRT neoadjuvant therapy in patients with advanced rectal cancer as the research object, with postoperative histopathological analysis as the reference index, and to assess the ability of patients to achieve pCR. A diagnostic model and evaluation system will also be constructed.
详细描述
- Correlation analysis between the expression levels of FAP and GLUT1 and the degree of tumor regression in rectal cancer
The study focuses on patients with advanced rectal cancer treated with SCRT neoadjuvant therapy, and conducts immunohistochemical staining of FAP and GLUT1 (glucose transporter 1) on postoperative specimens to evaluate histopathological changes related to the degree of rectal cancer tumor regression. The expression levels of FAP and GLUT1 and the grading of tumor regression are quantitatively analyzed, and their correlation is analyzed to explore the correlation between the expression levels of FAP and GLUT1 in the lesions of neoadjuvant therapy patients and the degree of tumor regression. 2. Construction and validation of a diagnostic model for the degree of tumor regression in rectal cancer after neoadjuvant therapy using 18F-FAPI combined with 18F-FDG PET/MRI imaging
The patient underwent preoperative 18F-FAPI and 18F-FDG PET/MRI imaging, followed by immunohistochemical staining of FAP and GLUT1 on postoperative specimens and evaluation of histopathological changes related to the degree of rectal cancer tumor regression. The patient's uptake of 18F-FAPI and 18F-FDG (SUVmax, SUVmean, SUVpeak, FAPI metabolic volume, MTV, TBR, TLG), expression levels of FAP and GLUT1, and degree of tumor regression were quantitatively analyzed, and the correlation between the patient's uptake of 18F-FAPI and 18F-FDG and the degree of tumor regression was explored. A graded diagnostic model and evaluation system were constructed to verify their effectiveness. 3. Comparison of the efficacy of PET/MR-TRG and MR-TRG in assessing pTRG after neoadjuvant therapy for rectal cancer
Compare the constructed PET/MR tumor regression grading diagnostic model with the commonly used clinical imaging diagnostic method MRI in evaluating the efficacy, pTRG, and pCR of neoadjuvant therapy for rectal cancer.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically confirmed as rectal adenocarcinoma, with baseline clinical staging of T3~4 and/or N+;
- •No distant metastasis;
- •Not receiving chemotherapy or any other anti-tumor treatment before enrollment;
- •Has not received immunotherapy before enrollment and is able to adhere to the protocol during the study period (neoadjuvant therapy of short-term radiotherapy sequential chemotherapy combined with immunotherapy);
- •After neoadjuvant therapy, 18F-FAPI and 18F-FDG PET/MRI imaging were performed within 7 days before surgery, and the two scans were collected over two days;
- •Patient age ≥ 18 years old
排除标准
- •Pregnant or lactating patients;
- •Patients with severe heart disease in clinical practice;
- •Organ transplantation requires immunosuppressive therapy and long-term use of hormone therapy;
- •Patients with autoimmune diseases;
- •Serious uncontrolled recurrent infections or other serious uncontrolled comorbidities;
- •The imaging quality is poor and cannot be used for diagnosis and evaluation;
- •Fasting blood glucose levels are higher than 11.1 mmol/L;
- •Patients with contraindications for MRI examination.
结局指标
主要结局
Evaluation efficacy of tumor regression level
时间窗: Completed within half year after end of the study
The sensitivity, specificity, positive predictive value (PPV), negative predictive value
次要结局
- expression of GLUT1(completed within one week after surgery)
- SUV(Completed within one week after PET examination)
- expression of FAP(completed within one week after surgery)
研究者
Xiao Chen
Director of Nuclear Medicine Department
Daping Hospital and the Research Institute of Surgery of the Third Military Medical University