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

NCT05108090 | Recruiting DMC

• 1 other identifier: CTO-OTHN-IUSCC-0741
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Squamous Cell Carcinoma; Nonmelanoma Skin Cancer; Cutaneous Squamous Cell Carcinoma

Keywords

sentinel lymph node biopsy

Outcome Measures

Primary Outcomes (1)

• Incidence of metastasis

  Incidence of occult metastasis in cT2-4N0 cutaneous squamous cell carcinoma (cSCC) of the head and neck by measuring the number of patients with positive sentinel lymph node biopsies.

  Baseline

Secondary Outcomes (3)

• Evaluate the tumor variables

  Baseline to 1 year

• Evaluate the gene profile via validated 40-gene expression profile (40-GEP) to identify common mutations associated with high-risk tumors characteristics.

  Baseline up to 1 year after reoccurrence occurs

• Evaluate the gene profile of tumor

  Baseline to 1 year

Study Arms (1)

Procedure/Surgery

OTHER

Mohs micrographic surgery followed by sentinel lymph node biopsy

Procedure: sentinel lymph node biopsy (SLNB)

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.

Procedure/Surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Melvin & Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

RECRUITING

MeSH Terms

Conditions

Carcinoma, Squamous Cell

Interventions

Sentinel Lymph Node Biopsy

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Squamous Cell

Intervention Hierarchy (Ancestors)

Biopsy; Cytodiagnosis; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Specimen Handling; Diagnostic Techniques, Surgical; Surgical Procedures, Operative; Lymph Node Excision; Investigative Techniques

Study Officials

• Jessica Yesensky, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Azeezat Yekinni

CONTACT

317-529-6883; ayekinn@iu.edu

Jessica Yesensky, MD

CONTACT

317- 948-3226

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 10, 2021
• First Posted: November 4, 2021
• Study Start: October 25, 2021
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)