Using MRI and ultrasound to diagnose small lymph node metastases in nasopharyngeal carcinoma patients
Combining MRI Scanning and Contrast-Enhanced Ultrasonography to Diagnose Small Cervical Lymph Node Metastases in Patients With Nasopharyngeal Carcinoma
This study is testing if using MRI and ultrasound together can help doctors find small lymph node cancer in patients with nasopharyngeal carcinoma more accurately.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 348 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-sen University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05389306 on ClinicalTrials.gov |
What this trial studies
This study aims to improve the diagnostic accuracy for small cervical lymph node metastases in patients with nasopharyngeal carcinoma by combining MRI and contrast-enhanced ultrasonography. Eligible patients will undergo MRI scanning to identify small lymph nodes, followed by ultrasound-guided lymph node aspiration for pathological evaluation. The study will assess the diagnostic performance of the combined imaging techniques and establish criteria for identifying metastases. The ultimate goal is to enhance the detection of lymph node involvement in nasopharyngeal carcinoma, which can impact treatment decisions.
Who should consider this trial
Good fit: Ideal candidates are patients with newly diagnosed, histologically confirmed nasopharyngeal carcinoma staged as T1-4, N0-1/N3, M0, with small lymph nodes detected on MRI.
Not a fit: Patients with a history of other malignant tumors or those who have undergone previous radiotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to earlier and more accurate diagnosis of lymph node metastases, improving treatment outcomes for patients with nasopharyngeal carcinoma.
How similar studies have performed: While the combination of MRI and contrast-enhanced ultrasonography is a novel approach in this context, similar studies have shown promise in improving diagnostic accuracy for other cancers.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-Sen University Cancer Center — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Study coordinator: Jun Ma, M.D.
- Email: majun2@mail.sysu.edu.cn
- Phone: +86-20-87343469
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.