Exploring the Application Value of PET Molecular Imaging Targeting FAP in Oral Squamous Cell Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Diagnostic performance (sensitivity, specificity, accuracy) and staging of FAPI PET in oral cancer
研究概览
简要总结
In this prospective study, the investigators will use integrated PET/CT with the agent 68Ga-FAPI and conventional imaging agent 18F-FDG to explore the application value of FAP-targeted molecular imaging in the diagnosis and staging for oral cancer. This study also aims to explore the application value of FAPI imaging in evaluating treatment response for oral cancer.
详细描述
Positron emission tomography (PET) molecular imaging provides a valuable method for the diagnosis, differential diagnosis and staging of various tumors. Cancer associated fibroblasts (CAFs) are the main components of tumor stroma, which are involved in tumor cell proliferation, invasion, metastasis and tumor angiogenesis, and play an important role in the occurrence and development of tumors. Fibroblast activation protein (FAP) is the most potential specific molecular marker of CAF, which is mainly expressed in stromal fibroblasts of epithelial tumors and is a potential molecular target for tumor diagnosis and treatment. Oral cancer is the most common type of malignant head and neck cancer, seriously endangering human health. Accurate delineation of the primary tumor, detection of regional nodal metastases, distant metastases and second primary tumors are important for determining the therapeutic strategy and prognosis of oral cancer. Currently, the molecular imaging agent most commonly used in clinical practice for oral cancer is 18F-fluoro-deoxy-glucose (18F-FDG). However, 18F-FDG exhibits some shortages. Inflammatory lesions and the surrounding normal tissue such as brain, tonsils and salivary glands show high uptake of 18F-FDG, often affecting the judgment of lesions.
Adult patients aged >18 years with clinically confirmed or highly suspected oral cancer will be enrolled. Participants receive paired baseline FDG and FAPI PET/CT to explore the diagnostic and staging value of FAPI PET in oral cancer. For resectable locally advanced cases receiving neoadjuvant therapy from oral and maxillofacial clinicians, a follow-up FAPI PET imaging will be performed after two cycles of treatment and before surgery to evaluate its application in treatment-response assessment. Ultimately, this study aims to comprehensively evaluate the clinical utility of FAPI PET/CT in oral cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- 否
入选标准
- •Voluntary participation with signed informed consent;
- •Aged 18~70 years;
- •Clinically highly suspected oral cancer and recurrence after treatment (Newly diagnosed patients: Scheduled for surgery or neoadjuvant therapy followed by surgery);
- •Ability to complete baseline and follow-up PET/CT (Follow-up FAPI PET/CT applies only to locally advanced patients undergoing neoadjuvant therapy.).
排除标准
- •Pregnant or breastfeeding women, or women planning pregnancy during the trial period;
- •Known hypersensitivity to FAPI, FDG, or their components, or history of severe allergic reactions;
- •People with poor general condition, their heart, lung, liver, kidney and other important organ functions cannot tolerate surgery;
- •Before the injection of 18F-FDG, the fasting blood glucose level exceeded 11.0 mmol/L;
- •Claustrophobia or inability to tolerate PET/CT imaging (Those who cannot tolerate lying supine for 15~30 minutes.);
- •Participation in another interventional clinical trial within 30 days prior to enrollment, or planned participation during this study.
研究组 & 干预措施
68Ga-DOTA-FAPI and 18F-FDG PET/CT
Investigators recruit patients whom are clinically highly suspected oral cancer or recurrence after treatment. Patients undergo baseline 68Ga-FAPI and 18F-FDG PET/CTwithin one week. For resectable locally advanced cases receiving neoadjuvant therapy from oral and maxillofacial clinicians, a follow-up FAPI PET imaging will be performed after two cycles of treatment and before surgery.
干预措施: 68Ga-DOTA-FAPI (Drug)
68Ga-DOTA-FAPI and 18F-FDG PET/CT
Investigators recruit patients whom are clinically highly suspected oral cancer or recurrence after treatment. Patients undergo baseline 68Ga-FAPI and 18F-FDG PET/CTwithin one week. For resectable locally advanced cases receiving neoadjuvant therapy from oral and maxillofacial clinicians, a follow-up FAPI PET imaging will be performed after two cycles of treatment and before surgery.
干预措施: PET/CT (Device)
68Ga-DOTA-FAPI and 18F-FDG PET/CT
Investigators recruit patients whom are clinically highly suspected oral cancer or recurrence after treatment. Patients undergo baseline 68Ga-FAPI and 18F-FDG PET/CTwithin one week. For resectable locally advanced cases receiving neoadjuvant therapy from oral and maxillofacial clinicians, a follow-up FAPI PET imaging will be performed after two cycles of treatment and before surgery.
干预措施: Participants receive baseline paired FDG and FAPI PET/CT. For resectable locally advanced cases receiving neoadjuvant therapy undergo follow-up FAPI PET imaging. (Diagnostic Test)
结局指标
主要结局
Diagnostic performance (sensitivity, specificity, accuracy) and staging of FAPI PET in oral cancer
时间窗: Baseline (at initial diagnosis, prior to treatment)
Comparison of FAPI PET and FDG PET in diagnosing oral cancer, including sensitivity, specificity, accuracy, and TNM staging. Assessments performed at baseline using histopathology and imaging as reference standards.
次要结局
- FAPI PET for therapeutic response evaluation(After completion of 2nd cycle of neoadjuvant therapy, just prior to surgery)
- Prognostic value of FAPI PET parameters in oral cancer(Through study completion, an average of 1 year)
- Correlation between FAPI PET parameters and histopathological biomarkers(At baseline and 6 weeks post-FAPI PET scan)