RecruitingNot ApplicableNCT05437380

Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC

The Value of Peritumoral Microbubbles and Contrast-enhanced Ultrasonography to Detect and Biopsy Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma


Sponsor

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

Enrollment

70 participants

Start Date

Sep 20, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

Head and neck squamous cell carcinoma is the sixth most common malignant tumor in the world. Cervical lymph node metastasis is frequently encounted on the date of diagnosis. Surgical resection is one of the most important treatment methods for head and neck squamous cell carcinoma with or without lymph node metastasis. At present, for cN0 patients, prophylactic neck dissection is recommended for squamous cell carcinoma originating in suprglottic, hypopharyngeal and oropharyngeal areas et al. Related studies reported that less than 30% of patients with cN0 were confirmed to have lymph node metastasis in postoperative pathological examination, who underwent neck dissection. Unnecessary neck dissection may increase complication incidence, such as neurovascular injury, chylous leakage, sialosyrinx. Accurate preoperative assessment is helpful to reduce unnecessary neck dissection. Sentinel lymph node biopsy were proved to be effective in reducing prophylactic lymph node dissection in breast cancer, melanoma and other malignant tumors. Compared with γ probe detection and indolyanine green injection, microbubble and contrast-enhanced ultrasound has no radiation and disturbance to resection margins in sentinel lymph nodes detection. Furthermore, surgeons could conduct lymph node puncture biopsy simultaneously under ultrasound guidance, which can further minimize surgical trauma. At present, the role of microbubble and contrast-enhanced ultrasound in sentinel lymph node detection and biopsy is rarely reported in head and neck squamous cell carcinoma. This study aims to explore the accuracy of peritumoral microbubbles and contrast-enhanced ultrasound for sentinel lymph nodes biopsy in predicting cervical lymph node metastasis in head and neck squamous cell carcinoma.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether microbubble contrast ultrasound (a special imaging technique using tiny bubbles injected near the tumor) can accurately identify the first lymph node a head and neck cancer is most likely to spread to — called the sentinel lymph node. Finding this node accurately helps surgeons decide if and where to remove lymph nodes. **You may be eligible if:** - You are between 18 and 70 years old - You have confirmed head and neck squamous cell carcinoma (a type of throat/mouth cancer confirmed by biopsy) - Scans show no suspected spread to neck lymph nodes - You are planning to have surgery to remove the tumor and also have neck lymph nodes removed **You may NOT be eligible if:** - You are allergic to microbubble contrast agents - You cannot tolerate surgery - Your scans already show enlarged or suspicious lymph nodes in the neck - Your cancer has already spread to distant parts of the body 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

DIAGNOSTIC_TESTperitumoral microbubbles and contrast-enhanced ultrasonography

Inject 1ml microbubbles around the tumors. Then detect lymph vessel and lymph nodes under contrast-enhanced ultrasonography.


Locations(1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, China

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NCT05437380


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