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

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor: Indiana University
Study ID: NCT05108090
Status: Recruiting

Apply to this trial

Conditions

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

sentinel lymph node biopsy (SLNB) — PROCEDURE
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.

Study Details

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.