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NCT Number: NCT06727162

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

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.

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Key information

Conditions

Head and Neck Squamous Cell Carcinoma Carcinoma Carcinoma, Squamous Cell Head and Neck Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial Squamous Cell Carcinoma of Head and Neck

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Guangzhou, Guangdong, China

Location status: Recruiting

Location contact

Lin Peiliang

CONTACT

[email protected]

86-020-34071539

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • (1) Histopathologically confirmed head and neck squamous cell carcinoma; (2) Received neoadjuvant chemoimmunotherapy; (3) Diagnosed with cN+ by CT/MRI before treatment; (4) Underwent radical surgical treatment plus cervical lymph node dissection at this center.

Exclusion criteria

  • (1) Did not receive a full course of neoadjuvant therapy; (2) History of treatment for head and neck; (3) Clinical evidence of distant metastasis found during preoperative examination.

Treatment and study plan

Contrast-Enhanced Ultrasound

Procedure

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.

Primary outcomes

  1. Sensitivity

    Time frame: From enrollment to the end of surgery at 10 weeks

    Sensitivity = True Positives / (True Positives + False Negatives).

  2. Specificity

    Time frame: From enrollment to the end of surgery at 10 weeks

    Specificity = True Negatives / (True Negatives + False Positives).

  3. Positive Predictive Value

    Time frame: From enrollment to the end of surgery at 10 weeks

    Positive Predictive Value = True Positives / (True Positives + False Positives)

  4. Negative Predictive Value

    Time frame: From enrollment to the end of surgery at 10 weeks

    Negative Predictive Value = True Negatives / (True Negatives + False Negatives)

Study contacts

Contact information is provided by the study sponsor or research team.

Lin Peiliang, Doctor

CONTACT

86-020-34071539

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Dec 10, 2024
Registry last updated
Dec 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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