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

NCT07518485 | Not Yet Recruiting Phase 2

• 1 other identifier: CHUV-DC-0037-preREDSEL-2023
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

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.

Conditions

N1/N2b Oral Cavity Cancer; Head and Neck Skin Cancer

Keywords

oral cavity cancer; head and neck skin cancer; patent blue V; indocyanine green; secondary sentinel lymph nodes

Outcome Measures

Primary Outcomes (2)

• 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)

Other Outcomes (1)

• Determining whether the dyed structures are lymph nodes

  During surgery (from dye-injection until end of surgery)

Study Arms (1)

Secondary lymph node detection

EXPERIMENTAL

Drug: Patent blue V dye injection; Drug: Indocyanine green dye injection

Interventions

Patent blue V dye injection DRUG

Patent Blue V dye is injected around the primary tumor.

Secondary lymph node detection

Indocyanine green dye injection DRUG

Indocyanine green dye is injected inside the metastatic lymph node(s).

Secondary lymph node detection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Vaudois: lead

Study Sites (2)

Centre Hospitalier Universitaire Vaudois (CHUV)

Lausanne, Canton of Vaud, 1011, Switzerland

Location

CHUV

Lausanne, Canton of Vaud, 1011, Switzerland

Location

MeSH Terms

Conditions

Mouth Neoplasms

Interventions

iso-sulfan blue

Condition Hierarchy (Ancestors)

Head and Neck Neoplasms; Neoplasms by Site; Neoplasms; Mouth Diseases; Stomatognathic Diseases

Central Study Contacts

Christian Simon, Professor

CONTACT

+41 21 314 05 39; christian.simon@chuv.ch

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 22, 2026
• First Posted: April 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-03

Locations

CH (2)