Prospective Clinical Study to Identify Secondary Sentinel... | NCT07518485

Studies
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

NCT07518485

Sponsor

Centre Hospitalier Universitaire Vaudois

Status

Not yet recruiting

Last Update Posted

Apr 8, 2026Actual

Enrollment

20Estimated

Phase

Phase 2

Conditions

N1/N2b Oral Cavity Cancer
Head and Neck Skin Cancer

Interventions

Patent blue V dye injection
Indocyanine green dye injection

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Mar 2026

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2026Estimated

Primary Completion Date

Mar 2027Estimated

Completion Date

Apr 2027Estimated

First Submitted Date

Mar 22, 2026

First Submission Date that Met QC Criteria

Apr 7, 2026

First Posted Date

Apr 8, 2026Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 7, 2026

Last Update Posted Date

Apr 8, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Secondary lymph node detection	Experimental		Drug: Patent blue V dye injection Drug: Indocyanine green dye injection

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Patent blue V dye injection	Drug	Patent Blue V dye is injected around the primary tumor.	Secondary lymph node detection

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of cases where the histopathological analysis of the dyed specimens confirms the presence of a lymph node		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		During surgery (from dye-injection until end of surgery)

Secondary Outcomes

Not provided

Other Outcomes

Measure	Description	Time Frame
Determining whether the dyed structures are lymph nodes	Overall outcome	During surgery (from dye-injection until end of surgery)

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christian Simon, Professor	Contact	+41 21 314 05 39		christian.simon@chuv.ch

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Centre Hospitalier Universitaire Vaudois (CHUV)		Lausanne	Canton of Vaud	1011	Switzerland
CHUV

ID	Term
D006258	Head and Neck Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D009059	Mouth Diseases
D009057	Stomatognathic Diseases