Clinical trial · Interventional
Sentinel Lymph Node Biopsy for Cutaneous Squamous Cell Carcinoma of the Head and Neck
NCT05108090CI-TRIAL-00090871recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cutaneous Squamous Cell Carcinoma | Skin Squamous Cell Carcinoma | ALIAS | 0.90 |
| Nonmelanoma Skin Cancer | Skin Carcinoma | ALIAS | 0.90 |
| Squamous Cell Carcinoma | Squamous Cell Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| sentinel lymph node biopsy (SLNB) | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Procedure/Surgery
- description
- Mohs micrographic surgery followed by sentinel lymph node biopsy
- interventionNames
- Procedure: sentinel lymph node biopsy (SLNB)
Primary outcomes (1)
- measure
- Incidence of metastasis
- timeFrame
- Baseline
- description
- 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.
Secondary outcomes (3)
- measure
- Evaluate the tumor variables
- timeFrame
- Baseline to 1 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.