Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC
Primary Purpose
Sentinel Lymph Node, Head and Neck Squamous Cell Carcinoma
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
peritumoral microbubbles and contrast-enhanced ultrasonography
Sponsored by
About this trial
This is an interventional diagnostic trial for Sentinel Lymph Node
Eligibility 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.
Sites / Locations
- Sun Yat-sen Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
CEUS
Arm Description
Outcomes
Primary Outcome Measures
diagnostic accuracy
diagnostic accuracy=(true positive+true negative)/(true positive+true negative+false positive+false negative)
Secondary Outcome Measures
Full Information
NCT ID
NCT05437380
First Posted
June 26, 2022
Last Updated
May 17, 2023
Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1. Study Identification
Unique Protocol Identification Number
NCT05437380
Brief Title
Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 20, 2022 (Actual)
Primary Completion Date
June 28, 2025 (Anticipated)
Study Completion Date
June 28, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sentinel Lymph Node, Head and Neck Squamous Cell Carcinoma
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
CEUS
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
peritumoral microbubbles and contrast-enhanced ultrasonography
Intervention Description
Inject 1ml microbubbles around the tumors. Then detect lymph vessel and lymph nodes under contrast-enhanced ultrasonography.
Primary Outcome Measure Information:
Title
diagnostic accuracy
Description
diagnostic accuracy=(true positive+true negative)/(true positive+true negative+false positive+false negative)
Time Frame
4 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lin Peiliang, M.D.
Phone
0086-020-34071439
Email
linpliang3@mail.sysu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Huang Xiaoming, M.D.
Organizational Affiliation
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sun Yat-sen Memorial Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lin Peiliang, M.D.
Phone
0086-020-3407-1439
Email
linpliang3@mail.sysu.edu.cn
First Name & Middle Initial & Last Name & Degree
Lin Peiliang, M.D.
First Name & Middle Initial & Last Name & Degree
Huang Xiaoming, M.D.
First Name & Middle Initial & Last Name & Degree
Xie Wenqian, M.D.
First Name & Middle Initial & Last Name & Degree
Liang Faya, M.D.
First Name & Middle Initial & Last Name & Degree
Ruan Jingliang, M.D.
12. IPD Sharing Statement
Learn more about this trial
Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC
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