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

NCT05389306 | Completed DMC

• 1 other identifier: 2022-FXY-041-FLK
• Study Type: interventional
• Target: 348
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Nasopharyngeal Carcinoma; Lymph Node; Diagnosis; Contrast-Enhanced Ultrasonography; Magnetic Resonance Imaging; Sonazoid

Outcome Measures

Primary Outcomes (2)

• Combined Diagnostic Criteria to Diagnose Small Cervical Lymph Node Metastases

  The criteria to diagnose small cervical lymph node metastases in patients with nasopharyngeal carcinoma by combining MRI scanning and contrast-enhanced ultrasonography with specific ultrasound contrast agents (Sonazoid).

  The pathologic results of the lymph nodes are expected to be obtained within one week after the MRI scanning, CEUS examination, and ultrasound-guided lymph node aspiration.

• Sensitivity and Specificity of the Combined Diagnostic Criteria

  The pathologic results of the lymph nodes are expected to be obtained within one week after the MRI scanning, CEUS examination, and ultrasound-guided lymph node aspiration.

Secondary Outcomes (5)

• Receiver Operating Characteristic Curve and Optimal Cut-off Value of Each Characteristics of Small Lymph Nodes in MRI Scanning and CEUS Examination

  The pathologic results of the lymph nodes are expected to be obtained within one week after the MRI scanning, CEUS examination, and ultrasound-guided lymph node aspiration.

• Diagnostic Performance of Each Characteristics of Small Lymph Nodes in MRI Scanning and CEUS Examination Based on the Optimal Cut-off Value

  The pathologic results of the lymph nodes are expected to be obtained within one week after the MRI scanning, CEUS examination, and ultrasound-guided lymph node aspiration.

• Inter-operator Agreement of Each Characteristics of Small Lymph Nodes in MRI Scanning and CEUS Examination

  The pathologic results of the lymph nodes are expected to be obtained within one week after the MRI scanning, CEUS examination, and ultrasound-guided lymph node aspiration.

• Diagnostic Performance of the Combined Diagnostic Criteria

  The pathologic results of the lymph nodes are expected to be obtained within one week after the MRI scanning, CEUS examination, and ultrasound-guided lymph node aspiration.

• Inter-operator Agreement of the Combined Diagnostic Criteria

  The pathologic results of the lymph nodes are expected to be obtained within one week after the MRI scanning, CEUS examination, and ultrasound-guided lymph node aspiration.

Study Arms (1)

MRI Scanning and CEUS for detection of small cervical lymph node metastases.

EXPERIMENTAL

All patients enrolled will undergo an MRI Scanning and CEUS to evaluate their cervical lymph nodes. Ultrasound-guided lymph node aspiration and pathologic examination will be performed subsequently to obtain definitive diagnosis of the lymph nodes. The pathologic results of the lymph nodes will be adopted as gold standard to evaluate the diagnostic performance of MRI Scanning, CEUS, and the combined diagnostic criteria.

Diagnostic Test: MRI Scanning; Diagnostic Test: Contrast-Enhanced Ultrasonography; Diagnostic Test: Ultrasound-guided Lymph Node Aspiration

Interventions

MRI Scanning DIAGNOSTIC_TEST

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.

MRI Scanning and CEUS for detection of small cervical lymph node metastases.

Contrast-Enhanced Ultrasonography DIAGNOSTIC_TEST

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.

MRI Scanning and CEUS for detection of small cervical lymph node metastases.

Ultrasound-guided Lymph Node Aspiration DIAGNOSTIC_TEST

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.

MRI Scanning and CEUS for detection of small cervical lymph node metastases.

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Eastern Cooperative Oncology Group performance status ≤1;
• Patients with histologically confirmed nasopharyngeal carcinoma;
• Tumor staged as T1-4, N0-1/N3, M0 (AJCC 8th);
• On at least one side of the patient's neck, no metastatic lymph nodes were found on MRI according to the current diagnostic criteria, but there were small lymph nodes with a minimal axial diameter ≥ 5 mm (6 mm for lymph node in level IIA);
• Patients must be informed of the investigational nature of this study and give written informed consent. And they should be willing and able to comply with the requirements of examination, treatment, follow-up and other research requirements stipulated in the research schedule.

You may not qualify if:

• History of other malignant tumors, except for adequately treated basal cell carcinoma, squamous cell carcinoma and cervical carcinoma in situ;
• Previous radiotherapy, except radiotherapy for non-melanoma skin cancer outside the neck or nasopharyngeal regions;
• Patients with coexistent head and neck squamous cell carcinoma besides nasopharyngeal carcinoma;
• Patients with coexistent acute inflammation or infection (including infection within the area for aspiration);
• Previous surgery or trauma within the neck or nasopharyngeal regions;
• Not suitable for aspiration due to abnormal coagulation function;
• All the candidate small lymph nodes with a minimal axial diameter ≥ 5 mm (6 mm for lymph node in level IIA) were not suitable for aspiration owing to high risk of severe complications after the aspiration；
• Contraindications for the examination specified in the research schedule due to claustrophobia, the presence of metal implants or pacemaker, and allergic hypersensitivity to ultrasound contrast agents or MRI contrast agents;
• Other situation assessed by the investigators that may compromise the safety or compliance of patients, such as serious disease requiring timely treatment (including mental illness), severe laboratory abnormalities, or family-social risk factors.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

Sun Yat-Sen University Cancer Center

Guangzhou, Guangdong, 510060, China

Location

MeSH Terms

Conditions

Nasopharyngeal Carcinoma; Disease

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Nasopharyngeal Neoplasms; Pharyngeal Neoplasms; Otorhinolaryngologic Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Nasopharyngeal Diseases; Pharyngeal Diseases; Stomatognathic Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: May 25, 2022
• Study Start: May 25, 2022
• Primary Completion: November 3, 2023
• Study Completion: November 7, 2023
• Last Updated: March 3, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)