Clinical Trial

Sentinel Lymph Node Mapping of Oral Cancer

Study Description

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

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.

Location

Locations Selected Location

Methods

Pharmaceutical medication involved Pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Procedure - Sentinel lymph node mapping

Thirty (30) 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 (Pinpoint, Novadaq, Waterloo ON). After the study, patients will continue with their planned management.

Drug - Indocyanine Green (ICG)

Device - near-infrared fluorescence (NIR) imaging (Pinpoint, Novadaq, Waterloo)

Additional Information

Official Study Title

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

Clinical Trial ID

NCT02478138

ParticipAid ID

penNPe