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.
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.
Study Type
OBSERVATIONAL
Enrollment
100
Intravenous access is pre-established. Quality control is carried out to confirm the radiochemical purity of 68Ga-DOTA-FAPI by HPLC. Intravenous administration of 68Ga-DOTA-FAPI according to 1.85-3.7 MBq/kg body weight (0.05-0.1 mCi/kg), rinsed with 0.9% saline, and hydrated after drinking more water.
Each subject undergoes PET/CT imaging within 20-30 minutes after injection.
Zhongnan Hopital of Wuhan University
Wuhan, Hubei, China
RECRUITINGDiagnostic performance (sensitivity, specificity, accuracy) and staging of FAPI PET in oral cancer
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.
Time frame: Baseline (at initial diagnosis, prior to treatment)
FAPI PET for therapeutic response evaluation
Assessment of FAPI PET parameters for predicting treatment response in patients receiving neoadjuvant therapy. Follow-up FAPI PET performed post-treatment.
Time frame: After completion of 2nd cycle of neoadjuvant therapy, just prior to surgery
Prognostic value of FAPI PET parameters in oral cancer
Correlation between FAPI PET parameters and long-term outcomes (e.g., progression-free survival, overall survival).
Time frame: Through study completion, an average of 1 year
Correlation between FAPI PET parameters and histopathological biomarkers
Correlation between FAPI PET parameters (SUVmax/SUVmean/SUVpeak) and histopathological biomarkers of tumor tissue. 1. FAP expression level (H-score; immunohistochemistry) 2. PD-L1 expression (Combined Positive Score; Dako 22C3 IHC assay) 3. CD8 expression (H-score; immunohistochemistry) 4. Granzyme B expression (H-score; immunohistochemistry)
Time frame: At baseline and 6 weeks post-FAPI PET scan
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This observational study evaluates the application of paired FDG and FAPI PET/CT in oral cancer. 1. Baseline phase: All participants undergo baseline FDG and FAPI PET/CT scans. 2. Post-neoadjuvant phase: For patients with resectable locally advanced disease receiving neoadjuvant therapy (as per clinician decision), a second FAPI PET/CT scan is performed after 2 cycles of treatment to assess treatment response. 3. Purpose: To explore the utility of FAPI PET in (a) initial staging, (b) treatment response evaluation, and (c) prognostic value in oral cancer.