FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) System
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).
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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
SLN detection rate — 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 — 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 — Up to 14 days post surgery Percentage of subjects with an SLN identified on MRI that is/are untreated by radiotherapy or surgery.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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