Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC

NCT05437380 | Recruiting

• 1 other identifier: SYSKY-2022-019-02
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Sentinel Lymph Node; Head and Neck Squamous Cell Carcinoma

Outcome Measures

Primary Outcomes (1)

• diagnostic accuracy

  diagnostic accuracy=(true positive+true negative)/(true positive+true negative+false positive+false negative)

  4 years

Study Arms (1)

CEUS

EXPERIMENTAL

Diagnostic Test: peritumoral microbubbles and contrast-enhanced ultrasonography

Interventions

peritumoral microbubbles and contrast-enhanced ultrasonography DIAGNOSTIC_TEST

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

CEUS

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Sun Yat-sen Memorial Hospital

Guangzhou, Guangdong, 510000, 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

Study Officials

• Huang Xiaoming, M.D.

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lin Peiliang, M.D.

CONTACT

0086-020-34071439; linpliang3@mail.sysu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: June 29, 2022
• Study Start: September 20, 2022
• Primary Completion: June 28, 2025
• Study Completion (Estimated): June 28, 2026
• Last Updated: March 25, 2025

Record last verified: 2024-05

Locations

CN (1)