N1/N2b Oral Cavity CancerPhase 2preReDSeLNCT07518485
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
A Phase 2 study testing Patent blue V dye injection and Indocyanine green dye injection in people with N1/N2b Oral Cavity Cancer and Head and Neck Skin Cancer, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- N1/N2b Oral Cavity Cancer, Head and Neck Skin Cancer
- What is being tested?
- Patent blue V dye injection and Indocyanine green dye injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesSwitzerland
- Study dates
- Apr 2026to Apr 2027
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
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- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites
Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1011
CHUV
Lausanne, Canton of Vaud, 1011
Virginie Zimmer, +41 79 556 69 47, virginie.zimmer@chuv.ch
About this study
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)
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.
- Being tested
- Patent blue V dye injection, Indocyanine green dye injection
- Keywords
- oral cavity cancer, head and neck skin cancer, patent blue V, indocyanine green, secondary sentinel lymph nodes
- Medical subject headings
- Mouth Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patent blue V dye injectionDrug
Patent Blue V dye is injected around the primary tumor.
Indocyanine green dye injectionDrug
Indocyanine green dye is injected inside the metastatic lymph node(s).
| Study group | Role | What they receive |
|---|---|---|
| Secondary lymph node detection | Experimental | Not described Receives: Drug: Patent blue V dye injection; Drug: Indocyanine green dye injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of cases where the histopathological analysis of the dyed specimens confirms the presence of a lymph node
Measured: 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
Measured: During surgery (from dye-injection until end of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionApr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for N1/N2b Oral Cavity CancerStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire VaudoisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Vaudois
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Simon, Centre Hospitalier Universitaire Vaudois
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07518485
- Sponsor's protocol ID
- CHUV-DC-0037-preREDSEL-2023
- Acronym
- preReDSeL
- Status last verified
- Mar 2026
- First submitted
- 22 Mar 2026
- Last updated
- 8 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07518485
- Acronym / sponsor ID
- preReDSeL / CHUV-DC-0037-preREDSEL-2023
- Keywords
- oral cavity cancer, head and neck skin cancer, patent blue V, indocyanine green, secondary sentinel lymph nodes
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire VaudoisUniversity, hospital or other
- Study start
- Apr 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 8 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Secondary lymph node detection | Experimental | Drug: Patent blue V dye injection, Drug: Indocyanine green dye injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patent blue V dye injectionPatent Blue V dye is injected around the primary tumor. | Drug | Secondary lymph node detection |
| Indocyanine green dye injectionIndocyanine green dye is injected inside the metastatic lymph node(s). | Drug | Secondary lymph node detection |
Primary outcome
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)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2026.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Patent blue V dye injection and Indocyanine green dye injection in people with N1/N2b Oral Cavity Cancer and Head and Neck Skin Cancer, run by Centre Hospitalier Universitaire Vaudois at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christian Simon, Professor (+41 21 314 05 39, christian.simon@chuv.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Apr 2026; AzTrials last refreshed its copy on 6 Nov 2026.