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

NCT06947759 | Not Yet Recruiting DMC

• 2 other identifiers: CF25181ATCVGH-1142401F
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Nuclear Medicine; Oncology

Keywords

PET/MRI; Nasopharyngeal carcinoma; EBV DNA

Outcome Measures

Primary Outcomes (3)

• Sensitivity of PET/MRI vs. PET/CT in Detecting Distant Metastases in NPC

  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.

  1 year

• Specificity Comparison Between PET/MRI and PET/CT in Detecting Distant Metastases in NPC

  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.

  1year

• Comparison of Overall Accuracy Between PET/MRI and PET/CT in Detecting Distant Metastases in NPC

  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.

  1 year

Secondary Outcomes (1)

• Comparison of Examination Costs Between PET/MRI and PET/CT in NPC Staging

  1 year

Interventions

PET/MRI RADIATION

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The participants in this study are pathologically diagnosed nasopharyngeal carcinoma (NPC) patients, primarily focusing on those with locally advanced staging (cT3-4/N2-N3), who have not yet received any treatment related to NPC. Participants must be 18 years or older, in good physical condition, and able to cooperate in completing imaging examinations and treatments.

You may qualify if:

• Pathologically diagnosed with nasopharyngeal carcinoma (NPC) through endoscopic biopsy at the hospital's otolaryngology department.
• Clinically staged as cT3-4/N2-N3.
• Age: 18 years and older.
• Participants must voluntarily sign an informed consent form, acknowledging understanding of the study objectives and potential risks.

You may not qualify if:

• Patients with poorly controlled diabetes. -Patients with a history of head and neck malignancies or a history of non- head and neck cancers with no evidence of disease for at least 3 years.
• Patients with clinical staging of cT1-2N0-1.
• Patients with factors that may affect PET/MRI image quality, such as implanted metal devices or MRI contraindications, or those with a history of contrast agent allergies.

Sponsors & Collaborators

• Taichung Veterans General Hospital: lead

Study Sites (1)

Taichung Veterans General Hospital

Taichung, Taiwan

Location

Related Publications (3)

• Feng Q, Liang J, Wang L, Ge X, Ding Z, Wu H. A diagnosis model in nasopharyngeal carcinoma based on PET/MRI radiomics and semiquantitative parameters. BMC Med Imaging. 2022 Aug 29;22(1):150. doi: 10.1186/s12880-022-00883-6.

  PMID: 36038819 BACKGROUND

• Fang Y, Chen S, Xu Y, Qiang M, Tao C, Huang S, Wang L, Chen X, Cao C. Assessment of bone lesions with 18 F-FDG PET/MRI in patients with nasopharyngeal carcinoma. Nucl Med Commun. 2023 Jun 1;44(6):457-462. doi: 10.1097/MNM.0000000000001682. Epub 2023 Mar 10.

  PMID: 36897049 BACKGROUND

• Cao C, Fang Y, Yu B, Xu Y, Qiang M, Tao C, Huang S, Chen X. Use of 18F-FDG PET/MRI as an Initial Staging Procedure for Nasopharyngeal Carcinoma. J Magn Reson Imaging. 2024 Mar;59(3):922-928. doi: 10.1002/jmri.28842. Epub 2023 May 31.

  PMID: 37256732 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Nasopharyngeal Carcinoma

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases

Central Study Contacts

Yi-Chun Liu, MD

CONTACT

886-4-23592525; b9202080@vghtc.gov.tw

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2025
• First Posted: April 27, 2025
• Study Start: April 30, 2025
• Primary Completion: March 31, 2026
• Study Completion: April 30, 2026
• Last Updated: April 27, 2025

Record last verified: 2025-03

Locations

TW (1)