Taichung Veterans General Hospital
Taichung, Taiwan
NCT Number: NCT06947759
This single-center prospective observational study aims to evaluate the feasibility, cost-effectiveness, and clinical value of positron emission tomography/magnetic resonance imaging (PET/MRI) for initial staging in patients with locally advanced nasopharyngeal carcinoma (NPC). It will compare the diagnostic performance of PET/MRI, including sensitivity, specificity, and staging accuracy, with traditional staging methods such as positron emission tomography/computed tomography (PET/CT).
Nasopharyngeal carcinoma is prevalent in Southeast Asia and North Africa, with approximately 5% of newly diagnosed cases presenting with distant metastases. For patients with N2-3 disease and elevated Epstein-Barr virus (EBV) DNA levels, the risk of distant metastasis can reach 27.5%. Accurate detection of distant metastases at diagnosis is crucial for staging and treatment planning. Current National Comprehensive Cancer Network (NCCN) guidelines recommend fluorodeoxyglucose (18F-FDG) PET/CT for staging in locally advanced nasopharyngeal carcinoma, as traditional tools (e.g., chest CT, abdominal ultrasound, bone scans) may yield false-negative results.
PET/MRI, as a novel imaging technique, offers potential advantages such as improved diagnostic accuracy, shorter scan times, and reduced false-positive rates. However, its clinical application is limited by high costs and equipment availability. This study will explore the clinical value and economic feasibility of PET/MRI in nasopharyngeal carcinoma staging, aiming to establish its potential role in improving diagnostic pathways.
Trial opening soon.
Get Notified18 year and older
All sexes
Observational
Taichung, Taiwan
Nasopharyngeal carcinoma (NPC) is prevalent in Southeast Asia and North Africa, with 5% of newly diagnosed cases showing distant metastases. For N2-3 stage patients with high Epstein-Barr virus (EBV) DNA levels, the metastasis rate can reach 27.5%. Accurate detection at diagnosis is crucial for staging and treatment planning. While the National Comprehensive Cancer Network (NCCN) recommends fluorodeoxyglucose (18F-FDG) positron emission tomography/computed tomography (PET/CT) for staging locally advanced NPC, traditional methods like chest CT or ultrasound may yield false negatives. PET/MRI offers improved accuracy and reduced false positives but is limited by high costs and low accessibility. This study examines the cost-effectiveness and clinical value of PET/MRI in NPC staging.
This study is a single-center prospective observational study. It will recruit patients aged 18 years or older with pathologically confirmed nasopharyngeal carcinoma (NPC) who have not received any NPC-related treatment and agree to participate. All participants will undergo PET/CT and PET/MRI to compare their diagnostic performance in detecting distant metastases, including sensitivity, specificity, and staging accuracy. The study will also evaluate the time efficiency and cost-effectiveness of PET/MRI to explore its clinical value and limitations.
This study aims to demonstrate that PET/MRI has superior diagnostic accuracy over PET/CT in staging locally advanced nasopharyngeal carcinoma, especially in detecting distant metastases. Despite higher costs, PET/MRI's accuracy may streamline diagnosis, reduce unnecessary tests, and support precise treatment strategies, improving patient outcomes and quality of life. The results will provide evidence for its clinical use and guide future diagnostic improvements.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This single-center prospective observational study targets patients pathologically diagnosed with nasopharyngeal carcinoma (NPC) and clinically staged as cT3-4/N2-N3. Participants will first undergo standard whole-body 18F-FDG PET/CT, followed by localized 18F-FDG PET/MRI of the head and neck within 4 hours. Both imaging procedures will be performed according to standard clinical protocols to ensure data consistency and comparability.
PET/MRI data will be independently interpreted by an experienced nuclear medicine physician and a radiologist. The sensitivity, specificity, and staging accuracy for detecting distant metastases will be analyzed. In cases of disagreement, a third physician will mediate to reach a consensus.
The study team will also record the operational time, direct costs, and potential issues encountered during the examination process for both imaging modalities. All participants will be followed for at least one year to validate imaging results and assess correlation
Time frame: 1 year
This study evaluates the sensitivity of PET/MRI compared to PET/CT in detecting distant metastases in nasopharyngeal carcinoma (NPC). Sensitivity is analyzed to determine the ability of each modality to accurately identify true-positive cases, validated through pathological confirmation and follow-up data.
Time frame: 1year
This study evaluates the specificity of PET/MRI and PET/CT in detecting distant metastases in nasopharyngeal carcinoma (NPC). Specificity, defined as the ability to correctly identify true-negative cases, is validated using pathological confirmation and follow-up data to assess the diagnostic accuracy of each imaging modality.
Time frame: 1 year
This study compares the overall accuracy of PET/MRI and PET/CT in detecting distant metastases in nasopharyngeal carcinoma (NPC). Overall accuracy is defined as the proportion of correct results (both true positives and true negatives) among all the cases, validated by pathological confirmation and follow-up data to assess the diagnostic effectiveness of each imaging modality.
Time frame: 1 year
This study compares the examination costs of PET/MRI and PET/CT in staging nasopharyngeal carcinoma (NPC). The analysis includes the direct costs associated with each imaging modality, such as equipment, personnel, and operational expenses, to evaluate the cost-effectiveness of both techniques in clinical practice.
Contact information is provided by the study sponsor or research team.
Taichung Veterans General Hospital
Other
Application of 18F-FDG PET/MRI as an Initial Staging Procedure for Locally Advanced Nasopharyngeal Carcinoma
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