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Combining MRI and CEUS to Diagnose Small Cervical Lymph Node Metastases in NPC Patients

NCT05389306 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2026-03-03

No results posted yet for this study

Summary

This is a single-center diagnostic accuracy study, with the purpose to define the criteria to diagnose small cervical lymph node metastases in patients with nasopharyngeal carcinoma by combining MRI scanning and contrast-enhanced ultrasonography and evaluate the diagnostic performance of the criteria.

Conditions

  • Nasopharyngeal Carcinoma

Interventions

DIAGNOSTIC_TEST

MRI Scanning

MRI scanning will be performed with a 3.0-T magnetic resonance imaging system with a head and neck-combined coil employing spin-echo technique. The range of the MRI scanning will be from the suprasellar cistern to the inferior margin of the sternal end of the clavicle. The section thicknesses for the axial plane, the sagittal plane and the coronal plane will be 5 mm, 3 mm and 2 mm, respectively. The intersection gaps will be 1 mm. Before the intravenous injection of the MRI contrast agents, T1 weighted images, T2 weighted images and diffusion weighted images will be obtained in the axial planes, while only T1 weighted images will be obtained in the sagittal and coronal planes. After the intravenous injection of the MRI contrast agents, T1-weighted axial sequence, T1-weighted sagittal sequences and T1-weighted fat-suppressed coronal sequence will be performed.

DIAGNOSTIC_TEST

Contrast-Enhanced Ultrasonography

A sonographer equipped with a 6-15 MHz linear array probe will be adopted for contrast-enhanced ultrasonography examination. Conventional high-frequency ultrasonography will be performed firstly before the intravenous injection of the ultrasound contrast agents. Then the ultrasound contrast agents will be injected intravenously, and contrast-enhanced ultrasonography examination will be performed. The mechanical index of contrast-enhanced ultrasonography examination will be 0.23. The wash-in and wash-out process within the lymph node will be dynamically observed during the arterial phase. During the Kupffer-phase, the degree of enhancement will also be observed.

DIAGNOSTIC_TEST

Ultrasound-guided Lymph Node Aspiration

After the conventional high-frequency ultrasonography and contrast-enhanced ultrasonography examination was finished, ultrasound-guided aspiration of the target lymph node will be performed. The lymph node tissue obtained from ultrasound-guided lymph node aspiration will be subjected to pathologic evaluation. And the diagnostic performance of MRI and contrast-enhanced ultrasonography will be evaluated using the pathologic diagnosis of the lymph node as the gold standard.

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-25
Primary Completion
2023-11-03
Completion
2023-11-07

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05389306 on ClinicalTrials.gov