60
Participants
Start Date
March 21, 2024
Primary Completion Date
February 28, 2026
Study Completion Date
February 28, 2029
FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) System
"FerroTrace will be injected peri-tumorally during the surgeons staging endoscopy, with an MRI conducted 12h to 28 days after injection. The MRI will be blinded to the clinical team and will assess the location of the primary draining lymph nodes (sentinel lymph nodes or SLNs).~Patients will proceed to standard of care neoadjuvant therapy and/or surgery. During surgery, indocyanine green (ICG) will be used to identify draining lymph nodes. Following surgery, pathologists will use FerroMag to identify SLNs which will undergo standard H\&E assessment, and if negative ultras-staging (fine serial slice and immunochemistry)."
NOT_YET_RECRUITING
Peter MacCallum Cancer Centre, Melbourne
NOT_YET_RECRUITING
Austin Hospital, Heidelberg
RECRUITING
Royal Adelaide Hospital, Adelaide
RECRUITING
Flinders Medical Centre, Bedford Park
Collaborators (2)
Royal Adelaide Hospital
OTHER
Austin Health
OTHER_GOV
Flinders Medical Centre
OTHER_GOV
Peter MacCallum Cancer Centre, Australia
OTHER
South Australian Health and Medical Research Institute
OTHER
Ferronova Pty Ltd
INDUSTRY