An observational study in Head and Neck Squamous Cell Carcinoma, sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-12-10.
Sponsored by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University · Observational
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.
6,741 studies on the registry are indexed under Carcinoma; 1,161 are open to participants now.
This study's planned enrollment of 100 is below the median of 149 across 1,175 observational studies indexed under Carcinoma.
Browse Carcinoma studies →Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University is the lead sponsor of 466 studies on the registry; 271 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with HNSCC, who treated in Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Exclusion Criteria:
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.
Sensitivity
Sensitivity = True Positives / (True Positives + False Negatives).
Time frame: From enrollment to the end of surgery at 10 weeks
Specificity
Specificity = True Negatives / (True Negatives + False Positives).
Time frame: From enrollment to the end of surgery at 10 weeks
Positive Predictive Value
Positive Predictive Value = True Positives / (True Positives + False Positives)
Time frame: From enrollment to the end of surgery at 10 weeks
Negative Predictive Value
Negative Predictive Value = True Negatives / (True Negatives + False Negatives)
Time frame: From enrollment to the end of surgery at 10 weeks
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University