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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

ConditionsN1/N2b Oral Cavity CancerHead and Neck Skin Cancer
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCentre Hospitalier Universitaire Vaudois

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • 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).

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Secondary lymph node detectionExperimental treatment 2 interventions

Trial outcomes

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)

Secondary outcomes

Other outcomes

1

Determining whether the dyed structures are lymph nodes

Overall outcome

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

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Universitaire Vaudois

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: