Sentinel Lymph Node Mapping of Oral Cancer Using Near-Infrared Fluorescence Imaging

• Status: Suspended
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Health Network, Toronto

Criteria

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