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

NCT05899985 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-04-06

No results posted yet for this study

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.

Conditions

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).

Sponsors & Collaborators

  • Royal Adelaide Hospital

    collaborator OTHER

  • Austin Health

    collaborator OTHER_GOV

  • Flinders Medical Centre

    collaborator OTHER_GOV

  • Peter MacCallum Cancer Centre, Australia

    collaborator OTHER

  • South Australian Health and Medical Research Institute

    collaborator OTHER

  • Ferronova Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Joe El-Aklouk · Ferronova Pty Ltd

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-21
Primary Completion
2026-05-30
Completion
2029-05-31

Countries

  • Australia

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05899985 on ClinicalTrials.gov