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 (preReDSeL)

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 (preReDSeL Study)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: N1/N2b Oral Cavity Cancer; Head and Neck Skin Cancer
• Intervention / Treatment: Drug: Patent blue V dye injection; Drug: Indocyanine green dye injection

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Christian Simon, Professor; Phone Number: +41 21 314 05 39; Email: christian.simon@chuv.ch

Study Locations

• Switzerland
  • Canton of Vaud
    • Lausanne, Canton of Vaud, Switzerland, 1011
      • Centre Hospitalier Universitaire Vaudois (CHUV)
    • Lausanne, Canton of Vaud, Switzerland, 1011
      • CHUV
      • Contact: Virginie Zimmer; Phone Number: +41 79 556 69 47; Email: virginie.zimmer@chuv.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Secondary lymph node detection	Drug: Patent blue V dye injection; Patent Blue V dye is injected around the primary tumor.; Drug: Indocyanine green dye injection; Indocyanine green dye is injected inside the metastatic lymph node(s).

What is the study measuring?

Primary Outcome Measures

Outcome 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)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determining whether the dyed structures are lymph nodes	Overall outcome	During surgery (from dye-injection until end of surgery)

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire Vaudois

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: March 22, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 8, 2026

Study Record Updates

• Last Update Posted (Actual): April 8, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: indocyanine green; oral cavity cancer; head and neck skin cancer; patent blue V; secondary sentinel lymph nodes
• Additional Relevant MeSH Terms: Mouth Diseases; Stomatognathic Diseases; Neoplasms by Site; Neoplasms; Head and Neck Neoplasms; Mouth Neoplasms; iso-sulfan blue
• Other Study ID Numbers: CHUV-DC-0037-preREDSEL-2023

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No