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Not yet recruiting NCT07518485

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

Phase II Interventional N1/N2b Oral Cavity Cancer Head and Neck Skin Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Patent blue V dye injection, Indocyanine green dye injection.
Who it may be relevant to
Registry conditions: N1/N2b Oral Cavity Cancer, Head and Neck Skin Cancer. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Switzerland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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)

Overview

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

  • 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).

Primary outcome measures

  • Percentage of cases where the histopathological analysis of the dyed specimens confirms the presence of a lymph node [Time frame: 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 [Time frame: During surgery (from dye-injection until end of surgery)]

Eligibility criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Other

Study locations

Switzerland · 2 centers
  • Centre Hospitalier Universitaire Vaudois (CHUV) — Lausanne
  • CHUV — Lausanne

Identifiers

NCT: NCT07518485 · CHUV-DC-0037-preREDSEL-2023

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗