Sentinel Lymph Node Biopsy for Cutaneous Squamous Cell Carcinoma of the Head and Neck
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorIndiana University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
sentinel lymph node biopsy (SLNB)
Procedure/SurgeryPreoperative 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.
Treatment groups
94 Participants
are divided into 1 treatment groupGroup A: Procedure/SurgeryOther 1 intervention
Trial outcomes
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.
Time frame
BaselineSecondary outcomes
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.)
Time frame
Baseline to 1 year2
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.
Time frame
Baseline up to 1 year after reoccurrence occurs3
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.
Time frame
Baseline to 1 yearSponsors and contacts
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Source ClinicalTrials.gov