Clinical trial · Interventional
Sentinel Lymph Node Biopsy for Cutaneous Squamous Cell Carcinoma of the Head and Neck
Sentinel Lymph Node Biopsy for Cutaneous Squamous Cell Carcinoma of the Head and Neck - A Multi-Institutional Prospective Study
- 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)
Current guidelines in management of regional lymph node metastases for cSCC patients include surgical resection with or without adjuvant therapy as well as chemotherapy and interdisciplinary management; in advanced disease, supportive and palliative care is recommended. These guidelines also define the role of SLNB in management of high-risk cSCC as unclear and suggest further studies need to determine its utility and indications11. Currently, routine practice of performing SLNB in cSCC varies across Quebec and within Canada. At many institutions, SLNB is not routinely performed on patients with cSCC. The current standard of treatment is to observe closely when a patient is deemed to have a high-risk cancer, and if they have clinical or radiological findings of lymphadenopathy, a formal surgical neck dissection is performed. Given the comorbidities and risks involved in treatment of regional lymph nodes in cSCC, the role of SLNB in cSCC patients needs further clarification. This multicentre prospective study aims to better clarify this role and formulate suggested criteria for its indications.
Conditions
Conditions (2)
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 |
| Sentinel Lymph Node | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sentinel Lymph Node Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Sentinel Lymph Node Biopsy
- description
- Lymphoscintigraphy will be ordered alongside usual pre-operative investigations. Intra-operatively, the excision of the primary tumor will be done with the aim of histologically clear margins and appropriate closure as per routine practice at the operating surgeon's discretion. The patients are injected with technicium 99 pre-operatively and a sentinel lymph node biopsy will be performed with a handheld gamma probe.
- interventionNames
- Procedure: Sentinel Lymph Node Biopsy
- type
- NO_INTERVENTION
- label
- Standard of Care
- description
- These patients will be treated with standard of care, which is wide local excision of the primary tumor without performance of sentinel lymph node biopsy, if not indicated.
Primary outcomes (1)
- measure
- predictive value of sentinel lymph node biopsy in cutaneous squamous cell carcinoma
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: high risk features rendering the patient eligible for SLNB in this study will include two or more of the following clinical or pathological features: * Immunocompromised * Size more than 2 cm * Depth more than 6 mm * Poorly differentiated histology * Perineural invasion \> 0.1mm * Extensive lymphovascular invasion Exclusion Criteria: * Evidence of lymph node metastasis (clinical, radiological, or pathological) * Previous surgery altering lymphatic drainage of the head and neck, such as a prior neck dissection or prior neck irradiation * Pregnancy of breast-feeding
References
Publications (0)
Data not yet available