Magnetic Sentinel Lymph Node Mapping in Upper Gastro-Intestinal Cancer: A Feasibility Clinical Investigation
This is a multi-centre, partially blinded, side-by-side comparator study to assess the safety and tolerability, feasibility, and potential added diagnostic and clinical value of using the FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) System for mapping sentinel lymph nodes (SLNs) in subjects with gastric, gastric-oesophageal junction, and oesophageal cancers, consisting of a safety lead-in phase and an expansion phase.
• Subject is capable of understanding and has provided written informed consent.
• Subject over 18 years of age and is fit to complete the study in the opinion of the investigator.
• Subject with a previously untreated histopathology confirmed diagnosis of gastric, gastric-oesophageal junction, oesophageal cancer and at the time of enrolment is expected to undergo curative-intent surgery.
• Females of childbearing potential must be willing to use methods of contraception as deemed adequate by the Investigator to be eligible for, and continue participation in, the study.
• In the opinion of the Investigator, the subject can complete the study in compliance with the Investigational Plan and is able to comply with the requirements of the Investigational Plan.
• Subjects with an Eastern Cooperative Oncology Group (ECOG) performance status of Grade 0-2.
• Additional tumour specific inclusion criteria for subjects in expansion cohorts as directed by the Sponsor.