Sentinel lymph node biopsy for cutaneous squamous cell carcinoma of the head and neck

Sentinel Lymph Node Biopsy for Head and Neck Skin Cancer

J
Jessica Yesensky, MD

Primary Investigator

Not Recruiting
18 years - 100 years
All
Phase N/A
94 participants needed
1 Location

Brief description of study

What is the purpose of this study?
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. 
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

 
  • During a baseline visit, researchers will complete a biopsy to confirm diagnosis of invasice cutaneous squamous cell carcinoma, as well as Spectral CT with contrast, MRI with contrast, PET-CT and/or PET-MRI.
  • During intervention, researchers will complete a pre-operative lymphoscintigraphy, surgery (either Moh's micrographic or standard excision), and gene profiling.
  • Participants will complete a follow-up visit approximately 1 week and 4 weeks after surgery, as well as every 3 months thereafter for 1 year. Researchers will review participant medical records related to the outcome of their SLNB for up to 2 years following surgery. 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Squamous Cell Carcinoma of the head or neck, Nonmelanoma Skin Cancer
  • Age: 18 years - 100 years
  • Gender: All

Inclusion Criteria:

  • 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 4 weeks of imaging


Exclusion Criteria:

  • 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

Updated on 25 Jun 2025. Study ID: CTO-OTHN-CC-IUSCC-0741, 2008504996

This study investigates the use of a biopsy technique called sentinel lymph node biopsy (SLNB) in patients with a type of skin cancer known as cutaneous squamous cell carcinoma located in the head or neck. The purpose is to see if SLNB can identify hidden tumor deposits in patients who do not show signs of cancer spreading to nearby lymph nodes. This type of cancer can be invasive, meaning it can spread to other parts of the body, which makes early detection important.

Participants will undergo several procedures as part of the study. Initially, a biopsy will confirm the diagnosis of the cancer. Additional imaging tests, such as Spectral CT, MRI, and PET scans, will be performed. During the intervention phase, a special imaging test called lymphoscintigraphy will be done before the surgery, which may involve Moh's micrographic surgery or standard excision. Gene profiling will also be conducted. Participants will have follow-up visits about 1 week and 4 weeks after surgery, and every 3 months for a year. Their medical records will be reviewed for up to 2 years to assess the outcomes of the SLNB.

  • Who can participate: Adults aged 18 and older with invasive cutaneous squamous cell carcinoma of the head or neck, staged T2-T4, and no signs of lymph node or distant metastasis can participate. Participants must be able to undergo general anesthesia and imaging with contrast.
  • Study details: Participants will have a biopsy and various imaging tests to confirm their cancer diagnosis. They will undergo surgery and special imaging to guide the procedure, followed by gene profiling. Follow-up visits will be conducted to monitor outcomes.

Interested in the study?

Select a study center that’s convenient for you, and get in touch with the study team.

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