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Squamous Cell CarcinomaNCT05108090

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

A study testing sentinel lymph node biopsy (SLNB) in people with Squamous Cell Carcinoma and Nonmelanoma Skin Cancer, run by Indiana University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
sentinel lymph node biopsy (SLNB)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
94 participants
Where
1 siteUnited States
Study dates
25 Oct 2021to Sep 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Azeezat Yekinni contact

317-529-6883

ayekinn@iu.edu

Jessica Yesensky, MD contact

317- 948-3226

United States1 site, 1 recruiting
  • Indiana University Melvin & Bren Simon Cancer Center

    Indianapolis, Indiana, 46202

    Recruiting

Other trials in United States

About this study

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.

Read the detailed description

Nonmelanoma skin cancer is the most commonly diagnosed malignancy in the United States, with cutaneous squamous cell carcinoma (cSCC) representing about 20% of those cases. It is estimated that there are 700,000 patients diagnosed each year in the United States and the incidence has been increasing worldwide. Most tumors are found within the sun-exposed areas of the head and neck. The vast majority require only local treatment, however there is a subset of patients who present with regionally metastatic disease. Retrospective reviews have determined factors associated with recurrence, metastasis, and disease-specific death include tumor size ≥ 2 cm, location on lip and ear, perineural and lymphovascular invasion, poorly differentiated histology, tumor extension beyond fat and immunosuppressed patients.

There have been multiple proposed staging schemes, including the American Joint Committee on Cancer (AJCC) and recently the Brigham and Women's Hospital (BWH) tumor staging. AJCC staging utilizes the size for early stage tumors, T1 < 2 cm and T2 ≥ 2 cm and less than 4 cm. Advanced tumors, T3 and T4 are stratified by aggressive features, including invasion beyond fat, perineural invasion (PNI), or bone/skull base erosion. BWH aimed to better stratify tumors by the number of aggressive features, T1 tumors with 0 features, T2a tumors with 1 feature, T2b with 2-3 features, and T3 with 4 or more features. High-risk features include tumor diameter ≥ 2 cm, poorly differentiated histology, PNI, tumor invasion beyond fat, or bone erosion. In a recent study, and found BWH provided superior prognostication for patients with localized cSCC as compared to AJCC7. However, BWH does not address regional or distant metastasis and therefore current treatment guidelines are based on BWH staging scheme. AAJCC systemCurrently, there is a general paucity of prospective data that can provide a consensus on risk-stratification of cutaneous squamous cell carcinomas and subsequent treatment algorithm. A consensus on risk-stratification for high-risk cSCC is lacking; consequently, treatment algorithm for primary tumors and nodal disease is not clear.

There is a subset of tumors with increased risk of local recurrence, nodal and distant metastasis which has yet to be elucidated. Data has shown metastasis to regional lymph nodes is the strongest predictor of recurrence and survival, and risk of nodal metastasis is noted to be 6% for all-comers and upwards of 20% for high-risk tumors. Therefore, detecting subclinical metastatic disease is extremely important for staging aggressive skin cancers and optimizing treatment.Imaging, including CT, MRI and PET, are considered for high-risk tumor. Data has demonstrated a higher risk of developing local recurrence, nodal metastasis and death from disease in patients that did not receive pre-treatment imaging as compared those who underwent imaging.

Guidelines recommend surgical excision of the primary tumor as first line treatment for cutaneous squamous cell carcinoma. Both Moh's micrographic surgery (MMS) and standard excision are both considered feasible surgical options. Available literature on management of lymph node metastasis largely limited to retrospective reviews and case series. Therefore, optimal management of regional lymph nodes for high-risk tumors remains unclear.

Sentinel lymph node biopsy (SNLB) is a common procedure utilized in multiple oncologic surgeries, especially dermatology. SLNB is recommended for aggressive skin cancers including melanoma and Merkel cell carcinoma. There is limited data on the utility of SLNB in nonmelanoma skin cancers, including cutaneous SCC. To date, there have been no prospective trials and current data comes from small retrospective studies. Therefore, the impact of SLNB on management and outcomes with high-risk cSCC remains unknown. Therefore, the impact of SLNB on cSCC remains unclear. The purpose of this study is to evaluate the rate of occult metastasis utilizing sentinel lymph node biopsy in clinically node-negative intermediate and high-risk cSCC.

Being tested
sentinel lymph node biopsy (SLNB)
Keywords
sentinel lymph node biopsy
Medical subject headings
Carcinoma, Squamous Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sentinel lymph node biopsy (SLNB)Procedure or surgery

    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 groups in NCT05108090
Study groupRoleWhat they receive
Procedure/SurgeryOtherMohs micrographic surgery followed by sentinel lymph node biopsy
Receives: Procedure: sentinel lymph node biopsy (SLNB)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline

Secondary outcomes (3)
  1. Evaluate the tumor variables

    Evaluate the tumor variables associated with occult metastasis using Fisher's exact tests for characteristics with categorical data and using logistic regression for characteristics with continuous data. (Tumor characteristics will be evaluated for their association with metastasis. Analyses will evaluate each of the characteristics individually using Fisher's exact tests for characteristics with categorical data and using logistic regression for characteristics with continuous data. No multivariable models will be assessed due to the small number of expected patients with metastasis. A 5% significance level will be used for all tests.)

    Measured: Baseline to 1 year

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

    Regional recurrence and distant metastasis confirmed by clinical, pathologic and radiographic evidence of metastasis.

    Measured: Baseline up to 1 year after reoccurrence occurs

  3. Evaluate the gene profile of tumor

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

    Measured: Baseline to 1 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Nov 2021
  2. Study start25 Oct 2021
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
94 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05108090
Sponsor's protocol ID
CTO-OTHN-IUSCC-0741
Status last verified
Jun 2025
First submitted
10 Oct 2021
Last updated
11 Jun 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing sentinel lymph node biopsy (SLNB) in people with Squamous Cell Carcinoma and Nonmelanoma Skin Cancer, run by Indiana University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Azeezat Yekinni (317-529-6883, ayekinn@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of metastasis (time frame: Baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.

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