Combining MRI and CEUS to Diagnose Small Cervical Lymph Node Metastases in NPC Patients (NPC-LN)

Sun Yat-sen University

Status: Enrolling

Conditions: Nasopharyngeal Carcinoma

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05389306

2022-FXY-041-FLK

Details and patient eligibility

About

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.

Full description

For newly diagnosed and histologically confirmed nasopharyngeal carcinoma patients staged as T1-4, N0-1/N3, M0 (AJCC 8th), if 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) on at least one side of the patient's neck, they will be eligible for this study. The MRI image of the small lymph nodes will be evaluated in details by experienced radiologists. Contrast-enhanced ultrasonography with specific ultrasound contrast agents (Sonazoid) and ultrasound-guided lymph node aspiration will be performed. Subsequently, the lymph node tissue obtained from ultrasound-guided lymph node aspiration will be subjected to pathologic evaluation. Using the pathologic diagnosis of the lymph node as the gold standard, diagnostic performance of MRI and contrast-enhanced ultrasonography will be evaluated. Resonable criteria to diagnose small cervical lymph node metastases by combining MRI scanning and contrast-enhanced ultrasonography will be explored. And the diagnostic performance of the criteria will be evaluated.

Enrollment: 348 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Eastern Cooperative Oncology Group performance status ≤1;
2. Patients with histologically confirmed nasopharyngeal carcinoma;
3. Tumor staged as T1-4, N0-1/N3, M0 (AJCC 8th);
4. 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);
5. 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.

Exclusion criteria

1. History of other malignant tumors, except for adequately treated basal cell carcinoma, squamous cell carcinoma and cervical carcinoma in situ;
2. Previous radiotherapy, except radiotherapy for non-melanoma skin cancer outside the neck or nasopharyngeal regions;
3. Patients with coexistent head and neck squamous cell carcinoma besides nasopharyngeal carcinoma;
4. Patients with coexistent acute inflammation or infection (including infection within the area for aspiration);
5. Previous surgery or trauma within the neck or nasopharyngeal regions;
6. Not suitable for aspiration due to abnormal coagulation function;
7. 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；
8. 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;
9. 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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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348 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Diagnostic Test: Ultrasound-guided Lymph Node Aspiration

Diagnostic Test: Contrast-Enhanced Ultrasonography

Diagnostic Test: MRI Scanning