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NCT06947759

Application of 18F-FDG PET/MRI for Initial Staging in Locally Advanced Nasopharyngeal Carcinoma

Sponsor: Taichung Veterans General Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Application of 18F-FDG PET/MRI as an Initial Staging Procedure for Locally Advanced Nasopharyngeal Carcinoma

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

20

Start Date

2025-04-30

Completion Date

2026-04-30

Last Updated

2025-04-27

Healthy Volunteers

No

Interventions

RADIATION

PET/MRI

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

Locations (1)

Taichung Veterans General Hospital

Taichung, Taiwan