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

NCT05899985 | Recruiting

• 1 other identifier: SMF-3
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 4

Brief 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

Gastric Cancer; Esophageal Cancer

Keywords

Sentinel lymph node

Outcome Measures

Primary Outcomes (3)

• SLN detection rate

  SLN detection rate and number of SLNs per subject using MRI and FerroMag following FerroTrace® injection and concordance between MRI and FerroMag

  Up to 14 days post surgery

• Ultra-staging diagnostic value

  Positive diagnostic value of FerroTrace® SLN mapping and SLN histopathological ultra-staging defined as the number of additional node negative (pN0/ypN0) subjects who are diagnosed with isolated tumor cells (pN0i+/ypN0i+), micro-metastasis (pN1mi/ypN1mi) and node positive (pN1/ypN1) by SLN ultra-staging plus standard of care histopathology versus standard of care histopathology only.

  Up to 14 days post surgery

• Surgical quality

  Percentage of subjects with an SLN identified on MRI that is/are untreated by radiotherapy or surgery.

  Up to 14 days post surgery

Secondary Outcomes (5)

• Rate of Adverse Events (AEs)

  The earlier of 28 days post FerroTrace injection or commencement of neoadjuvant therapy or surgery

• SLN Location Disease Free Survival

  Up to 5 years post surgery

• SLN Ultra-staging Disease Free Survival

  Up to 5 years post surgery

• SLN Location Overall Survival

  Up to 5 years post surgery

• SLN Ultra-staging Overall Survival

  Up to 5 years post surgery

Other Outcomes (3)

• FerroTrace and ICG Concordance

  Up to 14 days post surgery

• FerroTrace enhanced MRI Diagnosis

  Up to 14 days post surgery

• FerroTrace enhanced MRI Response

  Up to 14 days post surgery

Study Arms (1)

Single Arm

OTHER

Eligible subjects will undergo their normal standard of care treatment pathway with the added interventions described below.

Combination Product: FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) System

Interventions

FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) System COMBINATION_PRODUCT

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).

Single Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Subject has distant metastasis as detected on CT, PET, ultrasound guided fine needle aspiration (FNA), or cytology prior to enrolment.
• Subject started neoadjuvant therapy before informed consent, or prior to FerroTrace® administration.
• Subject has received a Feraheme® (ferumoxytol) injection within the past 180 days.
• Subject has a known or suspected history of allergies, hypersensitivity, or intolerances as follows:
• Iron compounds
• Polyacrylamide
• Polyethylene glycol (PEG) or has had an anaphylactic reaction to the Pfizer or Moderna COVID vaccines
• Iodine compounds
• Known or suspected hypersensitivity to FerroTrace®, or to any ingredients of FerroTrace®.
• Subject known to have haemochromatosis.
• Subjects with other known iron metabolism disorder(s) if the Investigator determines the subject is at a higher risk of iron toxicity.
• Subjects who at the time of enrolment are pregnant or lactating, or from the time of enrolment through to 14 days after injection of the study dose are trying to become pregnant, planning to impregnate a partner, or planning to donate sperm.
• Subject has one or more absolute contraindications to MRI scanning as per Investigator judgement.
• Subjects with an estimated glomerular filtration rate (eGFR) of \< 30 mL/min/1.73m2.
• Subject has inability or unwillingness to comply with all follow-ups through to the end of the study, and/or unwilling to allow review of medical records in accordance with local regulatory requirements at time of consent.

Sponsors & Collaborators

• Ferronova Pty Ltd: lead
• Royal Adelaide Hospital: collaborator
• Austin Health: collaborator
• Flinders Medical Centre: collaborator
• Peter MacCallum Cancer Centre, Australia: collaborator
• South Australian Health and Medical Research Institute: collaborator

Study Sites (4)

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

RECRUITING

Austin Hospital

Heidelberg, Victoria, 3084, Australia

NOT YET RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

NOT YET RECRUITING

MeSH Terms

Conditions

Stomach Neoplasms; Esophageal Neoplasms

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Stomach Diseases; Head and Neck Neoplasms; Esophageal Diseases

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Joe El-Aklouk

  Ferronova Pty Ltd

  STUDY DIRECTOR

Central Study Contacts

Markus Trochsler

CONTACT

+61 08 82226750; Markus.Trochsler@sa.gov.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-centre, partially blinded, side-by-side comparator study

Study Record Dates

• First Submitted: June 2, 2023
• First Posted: June 12, 2023
• Study Start: March 21, 2024
• Primary Completion: February 28, 2026
• Study Completion (Estimated): February 28, 2029
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

AU (4)