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

NCT06727162 | Recruiting

• 1 other identifier: SYSKY-2024-873-01
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (4)

• Sensitivity

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

  From enrollment to the end of surgery at 10 weeks

• Specificity

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

  From enrollment to the end of surgery at 10 weeks

• Positive Predictive Value

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

  From enrollment to the end of surgery at 10 weeks

• Negative Predictive Value

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

  From enrollment to the end of surgery at 10 weeks

Interventions

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with HNSCC, who treated in Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

You may qualify if:

• (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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: lead

Study Sites (1)

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

Guangzhou, Guangdong, China

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Lin Peiliang, Doctor

CONTACT

86-020-34071539

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2024
• First Posted: December 10, 2024
• Study Start: August 13, 2024
• Primary Completion: October 10, 2025
• Study Completion: October 10, 2025
• Last Updated: December 10, 2024

Record last verified: 2024-12

Locations

CN (1)