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Procedure

Sentinel Lymph Node Biopsy for Head and Neck Squamous Cell Carcinoma

N/A

Recruiting

Led By Jessica Yesensky, MD

Research Sponsored by Indiana University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Able to undergo general anesthesia for sentinel lymph node biopsy

Clinically and radiographically regional node-negative (no evidence of regional lymph node metastasis or distant metastasis)

Must not have

Patients unable to undergo general anesthesia

Known biopsy proven synchronous primary cutaneous squamous cell carcinoma

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 1 year

Awards & highlights

No Placebo-Only Group

Summary

This trial will test if SLNB can help find tumors in patients with node-negative cutaneous squamous cell carcinoma of the head or neck.

Who is the study for?

This trial is for adults over 18 with a specific skin cancer on the head or neck that hasn't spread to lymph nodes or elsewhere. They must be able to have general anesthesia, undergo certain scans with contrast, and consent to the study's procedures.

What is being tested?

The study tests if sentinel lymph node biopsy (SLNB) can detect hidden tumor cells in patients with cutaneous squamous cell carcinoma of the head or neck who don't show signs of cancer in their lymph nodes.

What are the potential side effects?

Potential side effects from SLNB may include pain, swelling, bruising at the biopsy site, allergic reactions to injected substances used for mapping lymph nodes, and very rarely nerve damage.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I can safely be put under general anesthesia for a biopsy.

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My scans show no cancer spread to nearby lymph nodes or distant areas.

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My skin cancer is in the head or neck area and is moderately to very advanced.

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I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I cannot have surgery that requires being put to sleep.

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I have a confirmed skin cancer diagnosis from a biopsy.

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My cancer has spread to nearby lymph nodes or other parts of my body.

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I cannot receive or am allergic to a specific diagnostic dye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of metastasis

Secondary study objectives

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.

Evaluate the tumor variables