Using microbubbles and ultrasound to detect lymph nodes in head and neck cancer
The Value of Peritumoral Microbubbles and Contrast-enhanced Ultrasonography to Detect and Biopsy Sentinel Lymph Nodes in Head and Neck Squamous Cell Carcinoma
This study is testing whether using special bubbles and ultrasound can help find lymph nodes in people with head and neck cancer to avoid unnecessary surgeries.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 70 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University Academic / other |
| Drugs / interventions | radiation |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05437380 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the use of peritumoral microbubbles combined with contrast-enhanced ultrasonography (CEUS) to improve the detection of sentinel lymph nodes in patients with head and neck squamous cell carcinoma (HNSCC). The goal is to accurately assess lymph node involvement preoperatively, potentially reducing the need for unnecessary neck dissections. By focusing on patients with no suspected lymph node metastasis, the study aims to enhance surgical outcomes and minimize complications associated with overtreatment. Participants will undergo imaging and subsequent surgical procedures based on the findings.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 with a confirmed diagnosis of head and neck squamous cell carcinoma and no suspected cervical lymph node metastasis.
Not a fit: Patients with known cervical lymph node metastasis or those who cannot tolerate surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more precise surgical interventions and reduced complications for patients with head and neck cancer.
How similar studies have performed: Previous studies have shown that sentinel lymph node biopsy can effectively reduce unnecessary lymph node dissections in other cancers, suggesting potential success for this approach in HNSCC.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Guangzhou, Guangdong
- Sun Yat-sen Memorial Hospital — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Huang Xiaoming, M.D. — Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Study coordinator: Lin Peiliang, M.D.
- Email: linpliang3@mail.sysu.edu.cn
- Phone: 0086-020-34071439
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.