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

Launched by INDIANA UNIVERSITY · Oct 24, 2021

Keywords

ClinConnect Summary

This clinical trial is exploring a specific type of biopsy called sentinel lymph node biopsy (SLNB) to see if it can effectively identify hidden tumor deposits in patients with cutaneous squamous cell carcinoma (a type of skin cancer) of the head and neck. The goal is to improve how doctors understand and treat this cancer when it has not spread to nearby lymph nodes, as detected through routine examinations and imaging.

To participate in this study, individuals must be at least 18 years old and have been diagnosed with invasive cutaneous squamous cell carcinoma that is classified as T2 to T4, meaning it has certain characteristics related to size and depth. Participants must also have no evidence of cancer spreading to regional lymph nodes or other areas of the body. Those who join can expect to undergo a sentinel lymph node biopsy, which will be performed under general anesthesia, and will be scheduled for surgery within eight weeks after initial imaging tests. It's important to note that individuals with certain conditions, such as evidence of cancer spread or those who are pregnant, will not be eligible for this trial.

Gender

ALL

Eligibility criteria

• 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