About this trial
This is an observational cohort study designed to (1) evaluate whether Gallium-68 (68Ga)-labeled fibroblast activation protein inhibitor ligand LM3 (68Ga-FAPI-LM3) positron emission tomography/computed tomography (PET/CT) improves the accuracy of nasopharyngeal carcinoma (NPC) staging, and (2) determine whether Gallium-68-labeled programmed death-ligand 1 (68Ga-PD-L1) PET/CT imaging parameters can provide early prediction of response to neoadjuvant immunotherapy. The study will assess the sensitivity and specificity of each tracer for staging and for predicting therapeutic response, analyze changes in tumor uptake parameters on 68Ga-FAPI-LM3 and 68Ga-PD-L1 PET/CT before and after treatment, and compare treatment efficacy and survival outcomes between patients with different degrees of residual PET uptake and between those who did and did not receive neoadjuvant immunotherapy. The primary question it aims to answer is:
Does 68Ga-FAPI-LM3 PET/CT improve the accuracy of NPC staging, and can 68Ga-PD-L1 PET/CT imaging parameters provide an early prediction of response to neoadjuvant immunotherapy?
Participants will be patients with biopsy-proven nasopharyngeal carcinoma who undergo 68Ga-FAPI-LM3 and/or 68Ga-PD-L1 PET/CT as part of clinical care or a research protocol. Tumor uptake metrics (e.g., maximum standardized uptake value (SUVmax), mean standardized uptake value (SUVmean), metabolic/volumetric indices) will be measured pre- and post-treatment; diagnostic performance (sensitivity, specificity) and associations between uptake changes and clinical outcomes (response rates, progression-free and overall survival) will be calculated.
Eligibility criteria
Qualifiers
Any sex; age 18-70 years.
Histologically confirmed non-keratinizing nasopharyngeal carcinoma (World Health Organization (WHO) type II or III).
Clinical stage I-IVA (American Joint Committee on Cancer (AJCC)/Union for International Cancer Control (UICC) 8th edition) with no evidence of distant metastasis.
Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
Disqualifiers
Pathological type of keratinizing squamous cell carcinoma or basaloid squamous cell carcinoma.
History of or concurrent other active (unresolved) malignant tumors, except for previously cured basal cell carcinoma of the skin, carcinoma in situ of the cervix, or superficial bladder cancer.
Currently participating in another clinical trial.
Pregnant or breastfeeding women.
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Locations
Sponsors and collaborators
The First Affiliated Hospital of Xiamen University
Lead sponsor
Sun Yat-Sen University Cancer Center
Collaborator
Peking University Shenzhen Hospital
Collaborator
Sichuan Cancer Hospital and Research Institute
Collaborator
Shandong Cancer Hospital and Institute
Collaborator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Collaborator
Shenzhen Yino Intelligence Technology Development Co.,Ltd.
Collaborator