Gastric CancerMAGMAPNCT05899985
Magnetic Sentinel Lymph Node Mapping in Upper Gastro-Intestinal Cancer: A Feasibility Clinical Investigation
A study testing FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) System in people with Gastric Cancer and Esophageal Cancer, run by Ferronova Pty Ltd at 4 sites in Australia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastric Cancer, Esophageal Cancer
- What is being tested?
- FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) System
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 4 sitesAustralia
- Study dates
- 21 Mar 2024to 31 May 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 18Show fewer
- 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.
- 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
Trial locations and contacts
4 sites in 1 country.
Australia4 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Flinders Medical Centre
Bedford Park, South Australia, 5042
Austin Hospital
Heidelberg, Victoria, 3084
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
About this study
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.
Read the detailed description
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 SLNM System for mapping SLNs in subjects with gastric, gastric-oesophageal junction, and oesophageal cancers, consisting of a safety lead-in phase and an expansion phase.
A safety lead-in phase will be adopted to determine the optimal dose for the expansion phase. For the safety lead-in phase, a minimum of 6 eligible subjects will undergo a FerroTrace® injection followed by Research magnetic resonance imaging (MRI) to visualise and assess SLNs. Safety will be monitored for 7 to 14 days, and will include reviews of safety, pharmacokinetics, image quality data from MRI pre and post FerroTrace® injection, and MRI SLN identification feasibility. Dose escalation/de-escalation may be performed using a 3+3 design if required. Upon successful completion of the safety lead-in phase, a dose of FerroTrace® will be selected for use in the expansion phase.
The expansion phase will consist of three cohorts of subjects (gastric, gastric-oesophageal junction, oesophageal cancers). Eligible subjects will undergo a FerroTrace® injection followed by a Research MRI to visualise and assess SLNs. If applicable a post neoadjuvant therapy Research MRI may be performed. The Research MRIs will be blinded to the multi-disciplinary team (MDT). During surgery a comparator product, Indocyanine green (ICG) with a near-infrared camera, will be used to identify fluorescent lymph nodes and in histopathology on ex-vivo specimens a magnetometer (FerroMag) will identify SLNs. The identification and location of all identified SLNs will be recorded, and all will be examined with fine serial sectioning and immunochemistry by pathology.
The study will assess disease free and overall survival and its correlation to histopathology and SLN location.
- Conditions
- Gastric Cancer, Esophageal Cancer
- Being tested
- FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) System
- Keywords
- Sentinel lymph node
- Medical subject headings
- Stomach Neoplasms, Esophageal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) SystemCombination 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).
| Study group | Role | What they receive |
|---|---|---|
| Single Arm | Other | Eligible subjects will undergo their normal standard of care treatment pathway with the added interventions described below. Receives: Combination Product: FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: Up to 14 days post surgery
Secondary outcomes (5)
Rate of Adverse Events (AEs)
Incidence, nature, severity, and relatedness to FerroMag or FerroTrace® of AEs and Serious Adverse Events (SAEs), changes of laboratory parameters, vital signs, and ECG results per NCI CTCAE v5.0
Measured: The earlier of 28 days post FerroTrace injection or commencement of neoadjuvant therapy or surgery
SLN Location Disease Free Survival
Disease free survival rates of subjects categorised by SLN location (MRI identified SLNs all treated/removed by radiotherapy/surgery versus some SLNs not treated/removed).
Measured: Up to 5 years post surgery
SLN Ultra-staging Disease Free Survival
Disease free survival rates of subjects categorised by histopathology after SLN ultra-staging.
Measured: Up to 5 years post surgery
SLN Location Overall Survival
Overall survival rates of subjects categorised by SLN location (MRI identified SLNs all treated/removed by radiotherapy/surgery versus some SLNs not treated/removed)
Measured: Up to 5 years post surgery
SLN Ultra-staging Overall Survival
Overall survival rates of subjects categorised by histopathology after SLN ultra-staging
Measured: Up to 5 years post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2023
- Study start21 Mar 2024
- Primary completion30 May 2026 (estimated)
- Study completion31 May 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastric CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multi-centre, partially blinded, side-by-side comparator study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ferronova Pty Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Royal Adelaide Hospital, Austin Health, Flinders Medical Centre, Peter MacCallum Cancer Centre, Australia, South Australian Health and Medical Research Institute
- Responsible party
- Sponsor
- Investigators
- Joe El-Aklouk, Study director, Ferronova Pty Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05899985
- Sponsor's protocol ID
- SMF-3
- Acronym
- MAGMAP
- Status last verified
- Mar 2026
- First submitted
- 2 Jun 2023
- Last updated
- 6 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Magnetic Sentinel Lymph Node Mapping in Upper Gastro-Intestinal Cancer: A Feasibility Clinical Investigation
- ClinicalTrials.gov ID
- NCT05899985
- Acronym / sponsor ID
- MAGMAP / SMF-3
- Conditions
- Gastric Cancer, Esophageal Cancer
- Keywords
- Sentinel lymph node
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Ferronova Pty LtdIndustry (pharma, biotech, devices)
- Collaborators
- Royal Adelaide Hospital, Austin Health, Flinders Medical Centre, Peter MacCallum Cancer Centre, Australia, South Australian Health and Medical Research Institute
- Study start
- 21 Mar 2024 (actual)
- Primary completion
- 30 May 2026 (estimated)
- Study completion
- 31 May 2029 (estimated)
- First posted
- 12 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 SLNM System for mapping SLNs in subjects with gastric, gastric-oesophageal junction, and oesophageal cancers, consisting of a safety lead-in phase and an expansion phase.
A safety lead-in phase will be adopted to determine the optimal dose for the expansion phase. For the safety lead-in phase, a minimum of 6 eligible subjects will undergo a FerroTrace® injection followed by Research magnetic resonance imaging (MRI) to visualise and assess SLNs. Safety will be monitored for 7 to 14 days, and will include reviews of safety, pharmacokinetics, image quality data from MRI pre and post FerroTrace® injection, and MRI SLN identification feasibility. Dose escalation/de-escalation may be performed using a 3+3 design if required. Upon successful completion of the safety lead-in phase, a dose of FerroTrace® will be selected for use in the expansion phase.
The expansion phase will consist of three cohorts of subjects (gastric, gastric-oesophageal junction, oesophageal cancers). Eligible subjects will undergo a FerroTrace® injection followed by a Research MRI to visualise and assess SLNs. If applicable a post neoadjuvant therapy Research MRI may be performed. The Research MRIs will be blinded to the multi-disciplinary team (MDT). During surgery a comparator product, Indocyanine green (ICG) with a near-infrared camera, will be used to identify fluorescent lymph nodes and in histopathology on ex-vivo specimens a magnetometer (FerroMag) will identify SLNs. The identification and location of all identified SLNs will be recorded, and all will be examined with fine serial sectioning and immunochemistry by pathology.
The study will assess disease free and overall survival and its correlation to histopathology and SLN location.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multi-centre, partially blinded, side-by-side comparator study
| Arm | Type | Receives |
|---|---|---|
| Single Arm | Other | Combination Product: FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) SystemEligible subjects will undergo their normal standard of care treatment pathway with the added interventions described below. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (18 listed)
- 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:
- Subject known to have haemochromatosis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) SystemFerroTrace 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). | Combination product | Single Arm |
Primary outcome
SLN detection rate
Time frame: Up to 14 days post surgery
SLN detection rate and number of SLNs per subject using MRI and FerroMag following FerroTrace® injection and concordance between MRI and FerroMag
Ultra-staging diagnostic value
Time frame: Up to 14 days post surgery
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.
Surgical quality
Time frame: Up to 14 days post surgery
Percentage of subjects with an SLN identified on MRI that is/are untreated by radiotherapy or surgery.
5 secondary outcomes
Rate of Adverse Events (AEs)
Time frame: The earlier of 28 days post FerroTrace injection or commencement of neoadjuvant therapy or surgery
SLN Location Disease Free Survival
Time frame: Up to 5 years post surgery
SLN Ultra-staging Disease Free Survival
Time frame: Up to 5 years post surgery
SLN Location Overall Survival
Time frame: Up to 5 years post surgery
SLN Ultra-staging Overall Survival
Time frame: Up to 5 years post surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe El-Aklouk study director
Ferronova Pty Ltd
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) System in people with Gastric Cancer and Esophageal Cancer, run by Ferronova Pty Ltd at 4 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
SLN detection rate (time frame: Up to 14 days post surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2026.