RecruitingNot ApplicableNCT05108090

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

Sponsor

Indiana University

Enrollment

94 participants

Start Date

Oct 25, 2021

Study Type

INTERVENTIONAL

Conditions

Cutaneous Squamous Cell Carcinoma Squamous Cell Carcinoma Nonmelanoma Skin Cancer

Summary

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.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether sentinel lymph node biopsy — a minimally invasive procedure to check nearby lymph nodes for cancer spread — can accurately detect if squamous cell skin cancer of the head and neck has spread to the lymph nodes. **You may be eligible if...** - You are 18 years or older - You have primary or recurrent squamous cell skin cancer of the head or neck (confirmed by biopsy), classified as stage T2–T4 - Your lymph nodes appear cancer-free on both physical examination and imaging - You are able to undergo general anesthesia and CT or MRI with contrast dye - Surgery is planned within 8 weeks of imaging **You may NOT be eligible if...** - There is already evidence of cancer in your lymph nodes or distant organs - You are unable to safely undergo anesthesia or contrast imaging - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREsentinel lymph node biopsy (SLNB)

Preoperative Lymphoscintigraphy: A standard injection of 2 mCi of 99m-Technetium sulfur colloid. Sequential immediate and delayed images will be obtained using SPECT/CT using a gamma probe. Ten-second counts will be done in areas of high activity to identify location of sentinel lymph node (SLN). After removal of the lymph node, a 10-second count will be done of the lymph node ex-vivo followed by 10-second count of the lymph node resection bed to ensure removal of SLN (less than 10% activity of LN). Surgical resection: Mohs micrographic surgery followed by SLNB. Intraoperative margins around the tumor will be confirmed through frozen section analysis. Patients with planned free flap reconstruction, will undergo SLNB with intraoperative, frozen section analysis. If lymph node is positive, immediate completion neck dissection will occur.