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

Inclusion Criteria7

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 Criteria6

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

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.