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RecruitingLast updated: 18 December 2025

MAGMAP: Evaluating a new scan to see whether it can more accurately help guide surgery and treatment decisions in people with previously untreated stomach, gastro-oesophageal junction and oesophagus cancers who are planning to have surgery to remove their cancerMagnetic Sentinel Lymph Node Mapping in Upper Gastro-Intestinal Cancer: A Feasibility Clinical Investigation

Trial purpose

Medical clipboardCancer treatment; Diagnostic

Tumor type

Upper gastrointestinal tract Cancers Upper gastrointestinal tract

Age

People18+

Trial acronym

MAGMAP

Clinical summary

Summary

This study will assess how safe, tolerable and feasible using the FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) System is for mapping sentinel lymph nodes, as well as what potential added diagnostic and clinical value it has. This will be tested in people with stomach, gastro-oesophageal junction, and oesophageal cancers.

The study consists of a safety lead-in phase to determine the optimal dose of FerroTrace® and an expansion phase where this will be further tested.

Safety lead-in phase
At least 6 participants will receive an injection of FerroTrace® , followed by a special research MRI scan to see how well the researchers can find certain lymph nodes (called sentinal lymphd nodes or SLNs). Participants will be monitored for 7-14 days to check for any side effects and review the scan results. If needed, the dose of FerroTrace® may be adjusted during this phase. Once they have confirmed the safest and most effective dose, they will move on to the next stage.

Expansion phase
In this phase, participants will be in groups based on their cancer type: gastric, gastro-oesophageal junction or oesophageal cancer. Each participant will receive the chosen dose of FerroTrace® and have a research MRI scan to look at lymph nodes. 

During surgery to remove the cancer, the researchers will also use another product called Indocyanine Green (ICG) with a special camera to help find lymph nodes. They will do this to see whther the FerroTrace  is more accurate than ICG or not. AFter surgery, the removed tissue will be carefully examined in the lab using advanced techniques to look for cancer cells.

 

Conditions

This trial is treating people with previously untreated gastric, gastro-oesophageal junction, or oesophageal cancer who are expected to undergo surgery to remove the cancer

Eligibility

Inclusion

  • 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.
  • Additional tumour specific inclusion criteria for subjects in expansion cohorts as directed by the Sponsor.

Exclusion

  • 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:

    1. Iron compounds
    2. Polyacrylamide
    3. Polyethylene glycol (PEG) or has had an anaphylactic reaction to the Pfizer or Moderna COVID vaccines
    4. Iodine compounds
    5. 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.
  • Investigator determines that the subject is not suitable for study participation for any other reason.
  • Subject received an investigational product (IP) within 30 days of FerroTrace® administration unless agreed by the sponsor.
  • Subjects have hyperthyroidism or benign thyroid nodules

Inclusion

  • Your cancer has not spread to other parts of the body (localised).
  • You have been diagnosed with cancer, but have not received any treatment.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria, and other criteria may apply for this trial. Ask your doctor about whether this trial could be right for you.

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Recruiting hospitals

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More information

Trial Identifiers

Information on this page is partially produced from ClinicalTrials.gov *. View further details about this trial on the registry via the links below:

Trial sponsor

Ferronova Pty Ltd

Scientific Title

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

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