Clinical Trial · NCT07139054

68Ga-FAPI-46 PET/CT for the Prediction of Clinical Response to Neoadjuvant Therapy in Nasopharyngeal Carcinoma Patients

Overview

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

Sponsor

The First Affiliated Hospital of Xiamen University

ClinicalTrials.gov

NCT07139054

Drug / Compound

FAPI-46

Isotope(s):

Target(s):

Ligand Class: Small Molecules

Chelator: DOTA

Eligibility

Inclusion

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);
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:
Histopathologically confirmed non-keratinizing nasopharyngeal carcinoma (WHO type II or III);
ECOG performance status score of 0 or 1;
Clinical stage III-IVa according to the AJCC/UICC 8th edition criteria, with no evidence of distant metastasis;

Exclusion

Patients with known hypersensitivity to ethanol.
Patients with a history of prior or concurrent malignant tumors that have not been cured, excluding cured basal cell carcinoma of the skin, cervical carcinoma in situ, and superficial bladder cancer;
The pathological type was keratinizing squamous cell carcinoma or basal-like squamous cell carcinoma.
Pregnant or lactating women;
According to the investigator's judgment, the subject has familial or social factors that may lead to premature termination of participation in the study, potentially affecting the subject's safety or the integrity of the study data;
Other severe comorbidities such as uncontrolled hypertension, severe cerebrovascular disease, severe renal disease, uncontrolled diabetes mellitus, and other chronic debilitating conditions;
Uncontrolled cardiovascular diseases, including myocardial ischemia or myocardial infarction of Grade II or higher, poorly controlled arrhythmias (including a QTc interval ≥ 470 ms); patients with NYHA Class III-IV heart failure or left ventricular ejection fraction (LVEF) \< 50% as assessed by echocardiography; myocardial infarction within the past year;
A history of substance abuse or alcohol dependence, psychiatric disorders, or individuals with no or limited civil capacity;
Participation in other clinical trials;