Sentinel Lymph Node Biopsy for Head and Neck Squamous Cell Carcinoma

Overseen By Azeezat Yekinni

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Pregnancy, Metastases, Allergic to contrast, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

94 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to research if a type of biopsy known as sentinel lymph node biopsy (SLNB) can help in determining the rate of tumor deposits that are hard to detect and identify in node-negative cutaneous squamous cell carcinoma of the head or neck.

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Sentinel Lymph Node Biopsy for Head and Neck Squamous Cell Carcinoma?

Research shows that Sentinel Lymph Node Biopsy (SLNB) is a promising method for staging head and neck squamous cell carcinoma, as it is minimally invasive and can accurately identify lymph nodes that may contain cancer. Studies indicate that SLNB is feasible and potentially effective in evaluating neck node metastasis, which helps in planning appropriate treatment. ^{1 2 3 4 5}

Is sentinel lymph node biopsy (SLNB) generally safe for humans?

Sentinel lymph node biopsy (SLNB) is considered a minimally invasive and generally safe procedure, initially developed for melanoma and breast cancers, and now used in head and neck cancers. It can help avoid unnecessary surgeries, reducing complications and improving quality of life. ^{2 3 4 6 7}

How is the treatment Sentinel Lymph Node Biopsy different from other treatments for head and neck squamous cell carcinoma?

Sentinel Lymph Node Biopsy (SLNB) is unique because it is a minimally invasive procedure that helps determine if cancer has spread to the lymph nodes, which is crucial for staging and treatment planning. Unlike traditional methods that may require more extensive surgery, SLNB focuses on identifying and testing only the first few lymph nodes (sentinel nodes) that drain the cancer area, potentially reducing the need for more invasive neck dissections. ^{1 3 4 5 8}

Research Team

Jessica Yesensky, MD

Principal Investigator

Indiana University

Eligibility Criteria

This trial is for adults over 18 with a specific skin cancer on the head or neck that hasn't spread to lymph nodes or elsewhere. They must be able to have general anesthesia, undergo certain scans with contrast, and consent to the study's procedures.

Inclusion Criteria

I can safely be put under general anesthesia for a biopsy.

Ability to provide written informed consent and HIPAA authorization

Able to undergo CT scan with contrast or MRI with contrast

Exclusion Criteria

I cannot have surgery that requires being put to sleep.

I have a confirmed skin cancer diagnosis from a biopsy.

My cancer has spread to nearby lymph nodes or other parts of my body.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Procedure/Surgery

Participants undergo Mohs micrographic surgery followed by sentinel lymph node biopsy

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after surgery and biopsy

1 year

Regular visits (in-person and virtual)

Treatment Details

Interventions

• Sentinel Lymph Node Biopsy

Trial Overview The study tests if sentinel lymph node biopsy (SLNB) can detect hidden tumor cells in patients with cutaneous squamous cell carcinoma of the head or neck who don't show signs of cancer in their lymph nodes.

Participant Groups

Group I: Procedure/Surgery Experimental Treatment 1 Intervention

Mohs micrographic surgery followed by sentinel lymph node biopsy

Sentinel Lymph Node Biopsy is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Sentinel Lymph Node Biopsy for:

• Breast cancer
• Melanoma
• Cutaneous squamous cell carcinoma of the head and neck

Approved in European Union as Sentinel Lymph Node Biopsy for:

• Breast cancer
• Melanoma
• Other types of cancer such as penile cancer, endometrial cancer, and vulvar cancer

Approved in Canada as Sentinel Lymph Node Biopsy for:

• Breast cancer
• Melanoma
• Other types of cancer

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Findings from Research

Sentinel node biopsy (SNB) is a highly effective staging technique for early-stage oral squamous cell carcinoma, achieving a 98% identification rate and a 99% surgical detection rate in a study of 90 patients.

The procedure demonstrated a high sensitivity of 93% and a negative predictive value of 97%, indicating that a negative SNB result is very reliable, with 100% overall survival for SNB-negative patients during a median follow-up of 18 months.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel node biopsy for early-stage oral cavity cancer: the VU University Medical Center experience. Den Toom, IJ., Heuveling, DA., Flach, GB., et al.[2019]

In a study of 33 patients with head and neck squamous cell carcinoma, sentinel lymph node biopsy (SLNB) demonstrated 100% sensitivity and negative predictive value in clinically node-negative (N0) patients, indicating it is highly effective for accurately staging these patients.

However, in clinically node-positive (N+) patients, SLNB had a lower sensitivity of 71% and a negative predictive value of 60%, suggesting it is not reliable enough to replace comprehensive neck dissection in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does sentinel lymph node biopsy have a role in node-positive head and neck squamous carcinoma? Edkins, O., Hofmeyr, C., Fagan, JJ.[2018]

Sentinel lymph node biopsy (SLNB) is a promising minimally invasive technique for staging cervical lymphatics in patients with head and neck squamous cell carcinoma (HNSCC), showing feasibility in various studies.

Current research, including a multicenter study by the American College of Surgeons Oncology Group, is investigating the accuracy of SLNB compared to standard elective neck dissection, highlighting the potential for lymphoscintigraphy to identify necessary lymphatic treatments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel node localization in head and neck tumors. Pitman, KT.[2016]

Sentinel lymph node biopsy (SLNB) for early head and neck squamous cell carcinoma (HNSCC) demonstrated a high identification rate of 95.2% and an accuracy of 95.0% across 16 studies involving 987 patients.

While SLNB showed a high sensitivity of 86.3%, it had a higher false-negative rate in SLNB alone trials compared to validation trials, indicating that the method's reliability may vary based on the study design.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnostic evaluation of sentinel lymph node biopsy in early head and neck squamous cell carcinoma: a meta-analysis. Yamauchi, K., Kogashiwa, Y., Nakamura, T., et al.[2019]

Sentinel node biopsy (SNB) shows promise in evaluating neck node metastasis in early-stage head and neck cancer, particularly in patients with untreated T1/2 oral cavity and oropharynx cancer, but it is currently recommended only within clinical trials due to the need for further validation.

Radiolabeled lymphoscintigraphy is more effective than blue dye for localizing sentinel lymph nodes, but the procedure is sensitive and requires careful pathological examination, as current intraoperative methods may miss small metastases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel node biopsy in head and neck squamous cell carcinoma. Kuriakose, MA., Trivedi, NP.[2009]

In a study of 36 patients with head and neck melanoma, sentinel lymph node biopsy (SLNB) was able to identify sentinel lymph nodes in 92% of cases, demonstrating its reliability in this region.

Despite the successful identification of sentinel lymph nodes, the study found no significant difference in recurrence-free and overall survival between patients with tumor-positive and tumor-negative nodes, indicating that SLNB did not impact disease outcomes in this small cohort.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does sentinel lymph node biopsy in cutaneous head and neck melanoma alter disease outcome? Doting, EH., de Vries, M., Plukker, JT., et al.[2016]

Sentinel lymph node biopsy (SLNB) is now established as a safe and effective method for assessing lymphatic spread in T1-T2N0 oral and oropharyngeal squamous cell carcinomas, allowing patients to potentially avoid unnecessary neck dissection and its associated morbidity.

Recent advancements in detection techniques, including intra-operative procedures and new tracers like tilmanocept, are improving the accuracy of SLNB, which may expand its applications in head and neck cancers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sentinel lymph node biopsy in head and neck oncology]. Moya-Plana, A., Guerlain, J., Casiraghi, O., et al.[2020]

Sentinel lymph node biopsy (SLNB) is crucial for accurately staging cutaneous malignancies in the head and neck (HN) region, which has complex lymphatic drainage and important anatomical structures.

This review confirms the reliability of SLNB in the HN, addressing previous uncertainties and providing guidance for its application in treatment planning and prognostic assessment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy for cutaneous head and neck malignancies. Dwojak, S., Emerick, KS.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Sentinel node biopsy for early-stage oral cavity cancer: the VU University Medical Center experience. [2019]

2. South Africa pubmed.ncbi.nlm.nih.gov

Does sentinel lymph node biopsy have a role in node-positive head and neck squamous carcinoma? [2018]

3. United States pubmed.ncbi.nlm.nih.gov

Sentinel node localization in head and neck tumors. [2016]

4. United States pubmed.ncbi.nlm.nih.gov

Diagnostic evaluation of sentinel lymph node biopsy in early head and neck squamous cell carcinoma: a meta-analysis. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Sentinel node biopsy in head and neck squamous cell carcinoma. [2009]

6. United States pubmed.ncbi.nlm.nih.gov

Does sentinel lymph node biopsy in cutaneous head and neck melanoma alter disease outcome? [2016]

7. France pubmed.ncbi.nlm.nih.gov

[Sentinel lymph node biopsy in head and neck oncology]. [2020]

8. England pubmed.ncbi.nlm.nih.gov

Sentinel lymph node biopsy for cutaneous head and neck malignancies. [2015]