Prospective Clinical Study to Identify Secondary Sentinel Lymph Nodes in Patients With N1/N2b Ora… (NCT07518485) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Prospective Clinical Study to Identify Secondary Sentinel Lymph Nodes in Patients With N1/N2b Oral Cavity or H&N Skin Cancers Using Patent Blue V and Indocyanine Green Dyes
Switzerland20 participantsStarted 2026-04
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. 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
✓. Signed study informed consent form for participation
Exclusion criteria
✕. 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
✕. Patients with known hyperthyroidism, thyroid autonomy (e.g., autonomous adenoma), or any thyroid disorder that may lead to increased iodine uptake
What they're measuring
1
Percentage of cases where the histopathological analysis of the dyed specimens confirms the presence of a lymph node
Timeframe: During surgery (from dye-injection until end of surgery)
2
Percentage of cases where the secondary sentinel lymph node status corresponds to the presence of disease in the rest of the dissected lymph nodes based on histopathology analysis
Timeframe: During surgery (from dye-injection until end of surgery)