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The goal of this clinical trial is to learn about the prediction of clinical response to neoadjuvant therapy in nasopharyngeal carcinoma patients via 68Ga-FAPI-46 PET/CT. The main question it aims to answer is:
Can 68Ga-FAPI-46 PET/CT be used to evaluate the therapeutic response of neoadjuvant therapy for nasopharyngeal carcinoma? The researchers will compare the correlation between the parameters obtained after three 68Ga-FAPI-46 PET/CT scans and the treatment response after neoadjuvant and neoadjuvant combined with concurrent chemoradiotherapy.
Participants will:
Undergo three 68Ga-FAPI-46 PET/CT scans before starting treatment, after neoadjuvant therapy, and after concurrent chemoradiotherapy
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| Measure | Description | Time Frame |
|---|---|---|
| Treatment response to neoadjuvant therapy in patients with nasopharyngeal carcinoma | Baseline, after induction chemotherapy and before concurrent chemoradiotherapy, after concurrent chemoradiotherapy |
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Inclusion Criteria:
Individuals of either gender, aged between 18 and 70 years;
Histopathologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III);
Clinical stage III-IVa according to the AJCC/UICC 8th edition criteria, with no evidence of distant metastasis;
ECOG performance status score of 0 or 1;
No prior anti-tumor treatment, including radiotherapy, chemotherapy, immunotherapy, or biological therapy, for nasopharyngeal carcinoma; ⑹ No contraindications to radiotherapy or chemotherapy; ⑺ Adequate major organ function as defined by the following criteria:
Hematologic criteria: WBC ≥ 4.0 × 10⁹/L, ANC ≥ 1.5 × 10⁹/L, PLT ≥ 100 × 10⁹/L, HGB ≥ 90 g/L (without blood transfusion, blood products, or hematopoietic growth factors such as G-CSF within the past 14 days);
Biochemical criteria: ALT and AST ≤ 2.5 × upper limit of normal (ULN); BUN and CRE ≤ 1.5 × ULN or creatinine clearance ≥ 60 ml/min (calculated using the Cockcroft-Gault formula); ⑻ Willing participation in the study, with signed informed consent, good compliance, and willingness to cooperate with follow-up procedures.
Exclusion Criteria:
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Patients with locally advanced nasopharyngeal carcinoma in the First Affiliated Hospital of Xiamen University.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Xiamen University | Xiamen | China |
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| ID | Term |
|---|---|
| D009303 | Nasopharyngeal Neoplasms |
| ID | Term |
|---|---|
| D010610 | Pharyngeal Neoplasms |
| D010039 | Otorhinolaryngologic Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D009371 | Neoplasms by Site |
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| D009369 | Neoplasms |
| D009302 | Nasopharyngeal Diseases |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D010038 | Otorhinolaryngologic Diseases |