Head and Neck Skin Cancer, N1/N2b Oral Cavity Cancer
Conditions
Keywords
oral cavity cancer, head and neck skin cancer, patent blue V, indocyanine green, secondary sentinel lymph nodes
Brief 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.
Interventions
DRUGPatent blue V dye injection
Patent Blue V dye is injected around the primary tumor.
DRUGIndocyanine green dye injection
Indocyanine green dye is injected inside the metastatic lymph node(s).
Sponsors
Centre Hospitalier Universitaire Vaudois
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Age ≥18 years 2. Operable SCC located in the oral cavity or the skin of the H\&N region, with one or two LNM 3. Primary disease 4. ECOG performance status 0-2 5. Signed study informed consent form for participation
Exclusion criteria
1. Non-operable tumors or contraindication to surgery 2. Previously treated head and neck cancer. Note: neoadjuvant treatment is not an exclusion criterion 3. Known hypersensitivity/allergy to triphenylmethane-based (Blue) dyes or to any of their components 4. Known hypersensitivity/allergy to indocyanine green or sodium iodide or iodine 5. Patients with known hyperthyroidism, thyroid autonomy (e.g., autonomous adenoma), or any thyroid disorder that may lead to increased iodine uptake 6. Patients with severe renal impairment (e.g., estimated glomerular filtration rate \<30 mL/min/1.73 m²) 7. Patients receiving beta-blocker therapy, as these medications may mask or reduce the response to anaphylactic reactions induced by dye injection 8. Pregnancy and/or ongoing breastfeeding 9. Any reason that would interfere with the patient's well-being and treatment as assessed by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percentage of cases where the histopathological analysis of the dyed specimens confirms the presence of a lymph node | During surgery (from dye-injection until end of surgery) |
| 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 | During surgery (from dye-injection until end of surgery) |
Countries
Switzerland
Contacts
CONTACTChristian Simon, Professor
Outcome results
None listed