MedDataX Logo

The Value of CEUS in Assessing the Response of Cervical Lymph Nodes After NACI for HNSCC

NCT ID: NCT06727162

Last Updated: 2024-12-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-13

Study Completion Date

2025-10-10

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Head and Neck Squamous Cell Carcinoma

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Contrast-Enhanced Ultrasound

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.

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* (1) Histopathologically confirmed head and neck squamous cell carcinoma; (2) Received neoadjuvant chemoimmunotherapy; (3) Diagnosed with cN+ by CT/MRI before treatment; (4) Underwent radical surgical treatment plus cervical lymph node dissection at this center.

Exclusion Criteria

* (1) Did not receive a full course of neoadjuvant therapy; (2) History of treatment for head and neck; (3) Clinical evidence of distant metastasis found during preoperative examination.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Guangzhou, Guangdong, China

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

China

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Lin Peiliang, Doctor

Role: CONTACT

Phone: 86-020-34071539

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Lin Peiliang

Role: primary

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SYSKY-2024-873-01

Identifier Type: -

Identifier Source: org_study_id