About this trial
Head and neck (H\&N) cancer has a poor prognosis and high morbidity with \~50% survival and frequent treatment resistance. Most deaths result from local or loco-regional progression rather than distant metastasis. Lymphatic spread to regional lymph nodes (RLNs), especially with extra-nodal extension (ENE), is a key predictor of poor outcomes. Current imaging techniques often miss micrometastases, leading to extensive but sometimes unnecessary neck treatments. Sentinel lymph node biopsy (SLNB) offers a precise method to detect early spread but is not yet widely adopted. Identifying second-echelon sentinel nodes-those receiving drainage from primary or first-tier nodes-may further refine treatment. The preReDSeL study evaluates the use of dyes (indocyanine green and Patent Blue V) for detecting these nodes. Success could reduce morbidity and guide tailored surgical/radiation therapy. The follow-up ReDSeL study will assess the clinical value of these findings.
Eligibility criteria
Qualifiers
Age ≥18 years
Operable SCC located in the oral cavity or the skin of the H&N region, with one or two LNM
Primary disease
ECOG performance status 0-2
Disqualifiers
Non-operable tumors or contraindication to surgery
Previously treated head and neck cancer. Note: neoadjuvant treatment is not an exclusion criterion
Known hypersensitivity/allergy to triphenylmethane-based (Blue) dyes or to any of their components
Known hypersensitivity/allergy to indocyanine green or sodium iodide or iodine
Trial design
Treatments tested in this trial
- Patent blue V dye injection
- Indocyanine green dye injection