Clinical trial · Interventional
Sentinel Lymph Node Mapping of Oral Cancer Using Near-Infrared Fluorescence Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Cervical lymph node involvement, in head and cancer neck patients, is one of the most important prognostic factors. Currently patients undergo neck dissection removing some or all nodes and neck involvement is retrospectively determined. Sentinel lymph node (SLN) identification and biopsy has become clinical practise in other areas including breast, skin, and gastric cancer. The gold standard for detecting metastatic lymph nodes is pathological analysis, but the lack of an accurate or clinically accepted way to identify sentinel lymph nodes in the cervical region has motivated the usage of indocyanine green (ICG) and near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo). A prospective clinical trial using a commercially available NIR system and ICG injection around the tumour site will evaluate the ability to detect and biopsy sentinel lymph nodes in head and neck cancer patients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Neoplasms | Head and Neck Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Indocyanine Green (ICG) | Drug | — | UNRESOLVED |
| near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo) | Device | — | UNRESOLVED |
| Sentinel lymph node mapping | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Surgical - therapeutic
- description
- patients will be enrolled under informed consent based upon their medical diagnosis, planned surgical procedures, and suitability for the procedure. During the study, patients will receive injections of ICG and will be imaged using a commercial NIR imaging system
- interventionNames
- Procedure: Sentinel lymph node mapping
- Drug: Indocyanine Green (ICG)
- Device: near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo)
Primary outcomes (1)
- measure
- ICG imaging to identify lymph nodes metastases in head and neck cancer
- timeFrame
- During surgical procedure
- description
- The aim of this proposal is to evaluate the potential application of Indocyanine Green (ICG) in the mapping and detection of sentinel lymph nodes (SLN) in cancers of the head and neck.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * The study will include patients with tumors or other masses in the following sites: oral cavity, oropharynx, nasal cavity, sinuses, nasopharynx, parapharyngeal space, parotid salivary glands, head and neck skin and skull base. * N0 neck status * The patients should have a complete and detailed medical record. * Subjects must be at least 18 years of age. * Subjects must sign and be given a copy of the written Informed Consent Form. Exclusion Criteria: * Patients who are not able to consent by themselves or grasp the implication of the study. * Subjects participating in any other clinical trial during the time of this clinical investigation and that may have an impact on this evaluation. * Pregnant or potentially pregnant woman * Lactation. * Iodine, shellfish, cough mixture, betadine or ICG allergy
References
Publications (0)
Data not yet available