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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a special biopsy, called sentinel lymph node biopsy (SLNB), can detect hidden tumor cells in individuals with a type of skin cancer on the head or neck. The main goal is to determine if SLNB can identify cancer that hasn't spread to the lymph nodes. Participants will undergo Mohs surgery, followed by SLNB, to check for any unnoticed cancer deposits. This trial may suit those diagnosed with advanced cutaneous squamous cell carcinoma on the head or neck without lymph node involvement. As an unphased trial, it offers an opportunity to contribute to research that could enhance detection methods for others in the future.

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 prior data suggests that this biopsy technique is safe for patients with head and neck squamous cell carcinoma?

Research has shown that sentinel lymph node biopsy (SLNB) is being explored for head and neck squamous cell carcinoma. This procedure helps doctors determine if cancer has spread to the lymph nodes.

Studies have found that most patients handle SLNB well. It is less invasive than other surgeries, such as neck dissection, usually involving less cutting and leading to quicker recovery.

In past research, patients who underwent SLNB often reported fewer issues with neck and shoulder movement afterward. This suggests the procedure might have fewer side effects than traditional surgeries.

While researchers continue to study SLNB for head and neck cancers, its use in other types of cancer has shown it to be generally safe. However, since it is still under investigation, researchers are closely monitoring it to ensure it remains safe and effective. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about sentinel lymph node biopsy for head and neck squamous cell carcinoma because it offers a more targeted approach compared to traditional methods like extensive neck dissection. This technique focuses on identifying and analyzing the first lymph node (or nodes) that cancer is likely to spread to, potentially sparing patients from more invasive procedures. By pinpointing the cancer's spread with greater accuracy, this method could lead to less tissue removal, reduced surgery time, and fewer side effects, which could significantly improve patient recovery and quality of life.

What evidence suggests that sentinel lymph node biopsy is effective for detecting tumor deposits in head and neck squamous cell carcinoma?

Research has shown that sentinel lymph node biopsy (SLNB) effectively treats early-stage oral squamous cell carcinoma, a type of cancer in the mouth. Studies have found that SLNB helps doctors detect small cancerous areas in lymph nodes that might otherwise be missed. In this trial, participants will undergo Mohs micrographic surgery followed by SLNB to assess its effectiveness for head and neck squamous cell carcinoma. SLNB is useful for understanding how the cancer spreads, especially when lymph nodes appear normal. One study found that removing the main tumor along with SLNB improved patient outcomes, achieving a 95% success rate. This suggests SLNB is a promising method for finding hidden cancer in head and neck cases. ^{3 5 6 7 8}

Who Is on the Research Team?

Jessica Yesensky, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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) 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]

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]

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 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) 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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38539488/

Sentinel Lymph Node Biopsy (SLNB) for Early-Stage Head ... This study, conducted at the ENT and Maxillofacial Surgery department of the Istituto Nazionale Tumori in Naples, explores SLNB's efficacy in ...

2. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2025.1507137/full

Imaging and sentinel lymph node biopsy in high risk head ... Complete excision of the primary site yields an impressive prognosis, with a success rate of 95% for head and neck cutaneous squamous cell ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1368837525004270

Sentinel lymph node biopsy in early-stage oral squamous ... Sentinel lymph node biopsy (SLNB) is an effective method for managing clinically node-negative (cN0) early-stage oral squamous cell carcinoma (OSCC).

4. ascopubs.org ascopubs.org/doi/10.1200/JCO.21.02781

Should Sentinel Lymph Node Biopsy Be Considered the ... Should sentinel lymph node biopsy be considered the new standard of care for early-stage clinically node-negative oral squamous cell carcinoma?

5. emedicine.medscape.com emedicine.medscape.com/article/854550-overview

Sentinel Lymph Node Biopsy for Squamous Cell Carcinoma SLNB can be a valuable staging technique for patients with cSCC or HNSCC whose lymphatic drainage has not been altered by previous surgery or radiotherapy.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3324960/

Sentinel lymph node biopsy in squamous cell carcinoma of ... SUMMARY. Sentinel node (SN) biopsy of head and neck cancer is still considered investigational, and agreement on the width of the surgical sampling has not yet ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10969103/

Sentinel Lymph Node Biopsy (SLNB) for Early-Stage Head ... This study presents the experience of a single center in sentinel lymph node biopsy (SLNB) as an alternative to elective neck dissection ...

8. nrgoncology.org nrgoncology.org/hn006

NRG-HN006: SLN Biopsy for ES Oral Cavity Cancer NRG-HN006 is a clinical study that seeks to determine if patient-reported neck and shoulder function and related quality of life is better six months after ...