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

Starting soon · Phase 2

Conditions studied: N1/N2b Oral Cavity Cancer, Head and Neck Skin Cancer

In brief

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.

Key facts

Study ID

NCT07518485

Run by

Centre Hospitalier Universitaire Vaudois

People needed

20

Starts

2026-04-01

Expected to finish

2027-04-01

Last updated by the study team

2026-04-08

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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
• Patients with severe renal impairment (e.g., estimated glomerular filtration rate <30 mL/min/1.73 m²)
• Patients receiving beta-blocker therapy, as these medications may mask or reduce the response to anaphylactic reactions induced by dye injection
• Pregnancy and/or ongoing breastfeeding
• Any reason that would interfere with the patient's well-being and treatment as assessed by the investigator

Where it is running

• Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne, Canton of Vaud, Switzerland
• CHUV — Lausanne, Canton of Vaud, Switzerland

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.