Recruiting

Sentinel Lymph Node Biopsy

Sponsor:

Indiana University

Code:

NCT05108090

Conditions

Squamous Cell Carcinoma

Nonmelanoma Skin Cancer

Cutaneous Squamous Cell Carcinoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

sentinel lymph node biopsy (SLNB)

Study Details

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

Study ID

NCT05108090

Start date

Oct 25, 2021

Status verified date

Jun, 2025

Completion date

Sep, 2026

Anticipated

Primary completion date

Sep, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

94 participants

Anticipated

Intervention Model

Single group

Primary purpose

Screening

Interventions and Outcome Measures

Arms

other: Procedure/Surgery

Mohs micrographic surgery followed by sentinel lymph node biopsy

Interventions

sentinel 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.

Primary outcome measure

  • Incidence of metastasis [ Time Frame: Baseline ]

Central Contacts and Locations

Central contacts

Azeezat Yekinni

317-529-6883ayekinn@iu.edu

Jessica Yesensky, MD

317- 948-3226

Locations

Indiana University Melvin & Bren Simon Cancer Center

Recruiting

Indianapolis, Indiana, United States, 46202

More Information

Sponsor

Indiana University

Last update posted

Jun 11, 2025

Last verified

Jun, 2025

Keywords

  • sentinel lymph node biopsy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Indiana University on 2025-06-11.