Magnetic Sentinel Lymph Node Mapping in Upper Gastro-Intestinal Cancer: A Feasibility Clinical Investigation

NARecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

March 21, 2024

Primary Completion Date

February 28, 2026

Study Completion Date

February 28, 2029

Conditions
Gastric CancerEsophageal Cancer
Interventions
COMBINATION_PRODUCT

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)."

Trial Locations (4)

3000

NOT_YET_RECRUITING

Peter MacCallum Cancer Centre, Melbourne

3084

NOT_YET_RECRUITING

Austin Hospital, Heidelberg

5000

RECRUITING

Royal Adelaide Hospital, Adelaide

5042

RECRUITING

Flinders Medical Centre, Bedford Park

Sponsors
All Listed Sponsors
collaborator

Royal Adelaide Hospital

OTHER

collaborator

Austin Health

OTHER_GOV

collaborator

Flinders Medical Centre

OTHER_GOV

collaborator

Peter MacCallum Cancer Centre, Australia

OTHER

collaborator

South Australian Health and Medical Research Institute

OTHER

lead

Ferronova Pty Ltd

INDUSTRY