Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC

Head and Neck Squamous Cell Carcinoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05437380
• Other study ID #: SYSKY-2022-019-02
• Status: Recruiting
• Phase: N/A
• Start date: September 20, 2022
• Est. completion date: June 28, 2026

Study information

• Verified date: June 2022
• Source: Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
• Contact: Lin Peiliang, M.D.
• Phone: 0086-020-34071439
• Email: linpliang3[@]mail.sysu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: June 28, 2026
• Est. primary completion date: June 28, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Aged 18-70;
• Pathological biopsy indicated head and neck squamous cell carcinoma;
• MR/CT examination indicate no suspected cervical lymph node metastasis;
• The patient intent to perform primary focal resection and unilateral/bilateral neck dissection at our center;
• agree to participate in clinical trials and sign informed consent.

Exclusion Criteria:

• allergic to microbubbles contrast agents;
• patients who cannot tolerate surgery;
• enlarged cervical lymph node in palpation or suspected cervical lymph node metastasis indicated in MR/CT examination;
• distant metastasis.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Squamous Cell
• Head and Neck Squamous Cell Carcinoma
• Sentinel Lymph Node
• Squamous Cell Carcinoma of Head and Neck

Intervention

Diagnostic Test:
• peritumoral microbubbles and contrast-enhanced ultrasonography
Inject 1ml microbubbles around the tumors. Then detect lymph vessel and lymph nodes under contrast-enhanced ultrasonography.

Locations

Country	Name	City	State
China	Sun Yat-sen Memorial Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnostic accuracy	diagnostic accuracy=(true positive+true negative)/(true positive+true negative+false positive+false negative)	4 years