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Sentinel Lymph Node Biopsy for Head and Neck Skin Cancer

This study is looking into whether a procedure called sentinel lymph node biopsy (SLNB) can help find small tumor deposits in people with cutaneous squamous cell carcinoma (a type of skin cancer) of the head or neck. This cancer is common, and while most cases are treated locally, some can spread. Researchers want to see if SLNB can identify these hard-to-detect tumor deposits in patients who don't show signs of cancer spread in their lymph nodes yet. You might be able to join if you are at least 18 years old and have primary or recurrent invasive cutaneous squamous cell carcinoma of the head or neck that is clinically staged T2-T4, and your regional lymph nodes appear clear of cancer. The main goal is to see how often cancer has spread (metastasis) at the start of the study.

Study design
This is an interventional study planning to enroll 94 participants. The study does not specify if it is randomized or blinded.
What's involved
You would undergo a sentinel lymph node biopsy (SLNB) procedure, which involves a special scan (lymphoscintigraphy) and then a biopsy to find and examine lymph nodes.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint, incidence of metastasis, is measured at Baseline, so no long-term follow-up is specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05108090

Sentinel Lymph Node Biopsy for Cutaneous Squamous Cell Carcinoma of the Head and Neck

Recruiting
NAAges 18+InterventionalScreening
Indiana University
~94 participants
Updated 2025-06-11 on ClinicalTrials.gov
What's tested:sentinel lymph node biopsy (SLNB)

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence of metastasis
Measured over Baseline

Conditions

Squamous Cell Carcinoma
Nonmelanoma Skin Cancer
Cutaneous Squamous Cell Carcinoma

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Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Indiana University Melvin & Bren Simon Cancer Center

    Indianapolis, Indianano site contact published

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Jessica Yesensky, MD · PRINCIPAL_INVESTIGATOR · Indiana University

Who to contact

Azeezat Yekinni
[email protected]
317-529-6883
Email the study team

Opens a ready-to-send draft in your own email app — review before sending.

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Eligibility criteria

Inclusion

Patients ≥ 18 years old at the time of informed consent
Ability to provide written informed consent and HIPAA authorization
Primary or recurrent invasive cutaneous squamous cell carcinoma of the head or neck, clinically staged T2-T4 based on AJCC staging
Clinically and radiographically regional node-negative (no evidence of regional lymph node metastasis or distant metastasis)
Able to undergo general anesthesia for sentinel lymph node biopsy
Able to undergo CT scan with contrast or MRI with contrast
Undergo surgical resection (Moh's or micrographic resection or standard excision with sentinel lymph node biopsy) within 8 weeks of imaging

Exclusion

Clinical evidence of satellite lesions, in-transit, regional nodal or distant metastases
Known biopsy proven synchronous primary cutaneous squamous cell carcinoma
Pregnant patients
Patients unable to undergo general anesthesia
Patient unable to receive contrasted imaging studies
Patient unable to receive and/or allergic to 99m-Technetium sulfur colloid

What this trial measures

  • Incidence of metastasisBaseline

    Incidence of occult metastasis in cT2-4N0 cutaneous squamous cell carcinoma (cSCC) of the head and neck by measuring the number of patients with positive sentinel lymph node biopsies.