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Dye technique could spare neck surgery for head and neck cancer patients

NCT ID NCT07518485

Knowledge-focused Sponsor: Centre Hospitalier Universitaire Vaudois Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tests whether injecting two dyes around the tumor and into cancerous lymph nodes can help surgeons spot hidden cancer spread in head and neck cancer. Twenty adults with oral cavity or head and neck skin cancer will receive the dyes before surgery. The goal is to see if this method can identify secondary lymph nodes that need removal, potentially reducing the extent of surgery and its side effects.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Patent Blue V dye and Indocyanine Green dye
What this could lead to
If successful, this technique could help doctors more accurately target cancer treatment, potentially reducing side effects from unnecessary lymph node removal.
What could go wrong
This is a small, early-phase study with only 20 participants, so results may not apply broadly. The dyes may not reliably detect all affected lymph nodes.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 20 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Apr 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

head and neck cancer Mouth Neoplasms oral cavity cancer oral cavity squamous cell carcinoma skin cancer skin squamous cell carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Head and neck skin cancer N1/N2B oral cavity cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • CHUV

    Lausanne, Canton of Vaud, 1011, Switzerland

  • Centre Hospitalier Universitaire Vaudois (CHUV)

    Lausanne, Canton of Vaud, 1011, Switzerland

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