Prospective Multi-Centre Phase II Validation Study of a New Lymphatic Imaging Protocol to Identify Drainage Patterns in Patients With Oropharyngeal Cancer

What this Trial Is About

Oropharyngeal cancer often spreads to lymph nodes in the neck, and treatment involves addressing both the original tumor and any spread to these nodes. Deciding whether to treat both sides of the neck can be challenging because the cancer may spread to the opposite side. This study aims to evaluate if a new imaging and surgical approach using sentinel node biopsy can more accurately determine if the cancer has spread to the other side of the neck, potentially improving treatment decisions. The study involves two main stages: imaging and surgery. In the imaging stage, a small amount of a radioactive tracer (either Human albumin colloidal particles or Lymphoseek) is injected near the tumor during an examination under anesthesia. A handheld gamma camera and a CT scan are used to detect the first lymph nodes (sentinel nodes) that the tracer reaches. In the surgery stage, patients with sentinel nodes detected on the opposite side of the neck may have those nodes removed during the examination under anesthesia to check for cancer spread. Some patients may also receive a second tracer injection under local anesthesia in an outpatient setting to test if it helps identify sentinel nodes before anesthesia. Participants will undergo tracer injections, imaging scans, and possibly node removal during examination under anesthesia. Researchers will measure how accurately the new imaging methods identify sentinel nodes on the opposite side of the neck, the number and location of these nodes, and patient acceptance using questionnaires. The study will monitor for hidden cancer spread in sentinel nodes and aims to provide better information about cancer spread without extra anesthesia. Participation may last throughout the imaging and surgical assessments as scheduled by the study.

Lymphatic Mapping Of Oropharyngeal Cancer