Magnetic map may improve cancer staging
NCT ID NCT05899985
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new magnetic tracer, FerroTrace, to find sentinel lymph nodes in people with stomach or esophageal cancer. About 60 participants will receive the tracer before standard treatment, and doctors will compare its accuracy to current methods. The goal is to see if this approach can better detect cancer spread and improve staging.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- FerroTrace (magnetic tracer) and FerroMag detection system
- What this could lead to
- If successful, this could provide a more accurate way to detect cancer spread in lymph nodes, potentially guiding better treatment decisions.
- What could go wrong
- This is an early feasibility study with only 60 participants, so results may not apply broadly. The magnetic tracer may not reliably identify all affected nodes.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 60 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2024
- Expected to finish
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May 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Austin Hospital
Heidelberg, Victoria, 3084, Australia
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Flinders Medical Centre
Bedford Park, South Australia, 5042, Australia
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Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000, Australia
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Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
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