NCT06727162

The Value of CEUS in Assessing the Response of Cervical Lymph Nodes After NACI for HNSCC

The Value of Contrast-enhanced Ultrasound in Assessing the Response of Cervical Lymph Nodes After Neoadjuvant Chemoimmunotherapy for Head and Neck Squamous Cell Carcinoma

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The head and neck squamous cell carcinoma is the sixth most common malignant tumor worldwide. For patients with locally advanced head and neck cancer, neoadjuvant therapy is recommended before surgery, including neoadjuvant chemotherapy and immunotherapy. There is a significant variation in patients' responses to neoadjuvant therapy, with approximately 37%-52% of patients achieving a complete pathological response after neoadjuvant therapy. Current research mainly focuses on the efficacy evaluation of the primary tumor, while there is less research on the treatment efficacy evaluation of cervical lymph nodes. In clinical practice, accurate assessment of the status of cervical lymph nodes after neoadjuvant chemoimmunotherapy in patients with squamous cell carcinoma of the head and neck can directly affect the choice of treatment plan by clinicians, reducing unnecessary neck dissection. In recent years, contrast-enhanced ultrasound has been widely used in the diagnosis of thyroid cancer and other head and neck tumors, as well as in the assessment of the benign and malignant nature of cervical lymph nodes. This study aims to explore the value of contrast-enhanced ultrasound in the assessment of cervical lymph nodes after neoadjuvant chemoimmunotherapy in squamous cell carcinoma of the head and neck, in order to guide clinicians in formulating personalized treatment plans.

Conditions

• Head and Neck Squamous Cell Carcinoma

Interventions

Type	Name	Description
PROCEDURE	Contrast-Enhanced Ultrasound	Participants are scanned in a supine position with the neck fully exposed. A routine ultrasound examination is first performed to assess the cervical lymph nodes. Assessment includes: number, size, location (zones I-VII), structure, echogenicity, margin, shape, hilum, calcification, and vascular distribution. After the routine ultrasound scan, the ultrasound system is switched to dual contrast-enhanced ultrasound mode. Sonazoid (GE Healthcare) is then administered intravenously through the antecubital vein at a dose of 0.015 mL/kg, followed by an injection of 5 mL of physiological saline. A timer is started after the injection, and video recording is made during the vascular phase from 5 to 60 seconds.

Timeline

• Start date: 2024-08-13
• Primary completion: 2025-10-10
• Completion: 2025-10-10
• First posted: 2024-12-10
• Last updated: 2024-12-10

Locations

1 site across 1 country: China