Combining MRI and CEUS to Diagnose Small Cervical Lymph Node Metastases in NPC Patients (NPC-LN)
Nasopharyngeal Carcinoma
About this trial
This is an interventional diagnostic trial for Nasopharyngeal Carcinoma focused on measuring Nasopharyngeal Carcinoma, Lymph Node, Diagnosis, Contrast-Enhanced Ultrasonography, Magnetic Resonance Imaging, Sonazoid
Eligibility Criteria
Inclusion Criteria:
- 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 II);
- 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:
- 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 II) 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.
Sites / Locations
- Sun Yat-Sen University Cancer CenterRecruiting
Arms of the Study
Arm 1
Experimental
MRI Scanning and CEUS for detection of small cervical lymph node metastases.
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.