NCT07518485Not yet recruiting
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
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.
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
Contacts
The trial team's contact details are shown on request.
See the official trial record- Status
- Not yet recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Countries
- Switzerland
- Sponsor
- Centre Hospitalier Universitaire Vaudois(Other)
- Protocol no.
- CHUV-DC-0037-preREDSEL-2023
- Conditions
- N1/N2b Oral Cavity Cancer, Head and Neck Skin Cancer
- Interventions
- Drug
Treatments studied
- Patent blue V dye injection
- Indocyanine green dye injection
Locations · 2
- Lausanne, SwitzerlandCentre Hospitalier Universitaire Vaudois (CHUV)Not yet recruiting at this site
- Lausanne, SwitzerlandCHUVNot yet recruiting at this site
In total, worldwide, both sites listed in the registry are planned; recruitment has not opened yet.
Site status per the ClinicalTrials.gov registry (last update posted: April 8, 2026).
This status may have changed and says nothing about your eligibility: before taking any step, check with your oncologist or the site.
See also
Other versions
These results are indicative and do not replace medical advice — discuss them with your doctor.