Using sentinel lymph node biopsy to assess cutaneous squamous cell carcinoma in the head and neck

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effectiveness of sentinel lymph node biopsy (SLNB) in detecting tumor deposits in patients with cutaneous squamous cell carcinoma (cSCC) of the head and neck. It focuses on patients who are clinically staged as T2-T4 and have no evidence of regional lymph node metastasis. The study aims to improve the identification of high-risk patients who may benefit from more aggressive treatment strategies. Participants will undergo SLNB along with surgical resection within eight weeks of imaging to evaluate the presence of undetected tumor deposits.

Why it matters

Who can join: the full rules

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 8 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

Where it's running

• Indiana University Melvin & Bren Simon Cancer Center
  Indianapolis, Indiana, United States Recruiting

Study contacts

• Principal investigator: Jessica Yesensky, MD — Indiana University
• Study coordinator: Azeezat Yekinni
• Email: ayekinn@iu.edu
• Phone: 317-529-6883

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.