Sentinel Lymph NodeNCT05437380
Peritumoral Microbubbles and CEUS for SLN Detection and Biopsy in HNSCC
A study testing peritumoral microbubbles and contrast-enhanced ultrasonography in people with Sentinel Lymph Node and Head and Neck Squamous Cell Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sentinel Lymph Node, Head and Neck Squamous Cell Carcinoma
- What is being tested?
- peritumoral microbubbles and contrast-enhanced ultrasonography
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteChina
- Study dates
- 20 Sep 2022to 28 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, Guangdong, 510000
Lin Peiliang, M.D., 0086-020-3407-1439, linpliang3@mail.sysu.edu.cn
Lin Peiliang, M.D.
About this study
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
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.
- Being tested
- peritumoral microbubbles and contrast-enhanced ultrasonography
- Medical subject headings
- Squamous Cell Carcinoma of Head and Neck
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
peritumoral microbubbles and contrast-enhanced ultrasonographyDiagnostic test
Inject 1ml microbubbles around the tumors. Then detect lymph vessel and lymph nodes under contrast-enhanced ultrasonography.
| Study group | Role | What they receive |
|---|---|---|
| CEUS | Experimental | Not described Receives: Diagnostic Test: peritumoral microbubbles and contrast-enhanced ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
diagnostic accuracy
diagnostic accuracy=(true positive+true negative)/(true positive+true negative+false positive+false negative)
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start20 Sep 2022
- Primary completion28 Jun 2025 (estimated)
- Study completion28 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sentinel Lymph NodeStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Huang Xiaoming, M.D., Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05437380
- Sponsor's protocol ID
- SYSKY-2022-019-02
- Status last verified
- May 2024
- First submitted
- 26 Jun 2022
- Last updated
- 25 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05437380
- Acronym / sponsor ID
- SYSKY-2022-019-02
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 20 Sep 2022 (actual)
- Primary completion
- 28 Jun 2025 (estimated)
- Study completion
- 28 Jun 2026 (estimated)
- First posted
- 29 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CEUS | Experimental | Diagnostic Test: peritumoral microbubbles and contrast-enhanced ultrasonography |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| peritumoral microbubbles and contrast-enhanced ultrasonographyInject 1ml microbubbles around the tumors. Then detect lymph vessel and lymph nodes under contrast-enhanced ultrasonography. | Diagnostic test | CEUS |
Primary outcome
diagnostic accuracy
Time frame: 4 years
diagnostic accuracy=(true positive+true negative)/(true positive+true negative+false positive+false negative)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Huang Xiaoming, M.D. principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing peritumoral microbubbles and contrast-enhanced ultrasonography in people with Sentinel Lymph Node and Head and Neck Squamous Cell Carcinoma, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lin Peiliang, M.D. (0086-020-34071439, linpliang3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
diagnostic accuracy (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2025.