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NCT Number: 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

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.

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Key information

Conditions

N1/N2b Oral Cavity Cancer Head and Neck Neoplasms Head and Neck Skin Cancer Mouth Diseases Mouth Neoplasms Neoplasms Neoplasms by Site Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

CHUV, Lausanne, Canton of Vaud, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Patent blue V dye injection

Drug

Patent Blue V dye is injected around the primary tumor.

Indocyanine green dye injection

Drug

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

Primary outcomes

  1. 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)

  2. 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)

Other outcomes

  1. Determining whether the dyed structures are lymph nodes

    Time frame: During surgery (from dye-injection until end of surgery)

    Overall outcome

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire Vaudois

Other

Registry information

Official study 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)

Acronym: preReDSeL

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 8, 2026
Registry last updated
Apr 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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