RecruitingNCT06727162

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


Sponsor

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Enrollment

100 participants

Start Date

Aug 13, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is looking at whether a special type of ultrasound scan (called contrast-enhanced ultrasound, or CEUS) can accurately measure how well lymph nodes in the neck respond to treatment in people with head and neck squamous cell cancer. This could help doctors better plan whether additional surgery is needed. **You may be eligible if...** - You have been confirmed by biopsy to have squamous cell cancer of the head and neck - You received chemo-immunotherapy before surgery (called neoadjuvant treatment) - Imaging before treatment showed cancer had spread to your neck lymph nodes - You underwent surgery including removal of neck lymph nodes at the treating hospital **You may NOT be eligible if...** - You did not complete the full course of pre-surgery treatment - You had previous head or neck cancer treatment - Scans showed the cancer had spread to distant parts of the body before surgery Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREContrast-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.


Locations(1)

Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

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NCT06727162


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