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ACTIVE NOT RECRUITING
NCT05899985
NA

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

Sponsor: Ferronova Pty Ltd

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-03-21

Completion Date

2029-05-31

Last Updated

2026-04-06

Healthy Volunteers

No

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).

Locations (4)

Royal Adelaide Hospital

Adelaide, South Australia, Australia

Flinders Medical Centre

Bedford Park, South Australia, Australia

Austin Hospital

Heidelberg, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia