Mapping lymph nodes in upper gastrointestinal cancer using FerroTrace®
Magnetic Sentinel Lymph Node Mapping in Upper Gastro-Intestinal Cancer: A Feasibility Clinical Investigation
This study is testing a new injection called FerroTrace® to see if it can help doctors find important lymph nodes during surgery for patients with stomach and esophagus cancers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ferronova Pty Ltd Industry-sponsored |
| Locations | 4 sites (Adelaide, South Australia and 3 other locations) |
| Trial ID | NCT05899985 on ClinicalTrials.gov |
What this trial studies
This clinical investigation evaluates the safety, tolerability, and feasibility of the FerroTrace® and FerroMag Sentinel Lymph Node Mapping System in patients with gastric and esophageal cancers. The study consists of a safety lead-in phase, where a small group of subjects will receive FerroTrace® injections followed by MRI imaging to assess lymph node mapping. If successful, the study will proceed to an expansion phase involving larger cohorts to further evaluate the diagnostic value of this approach. The research aims to improve the identification of sentinel lymph nodes during surgery, potentially enhancing surgical outcomes.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with untreated gastric or esophageal cancer who are expected to undergo curative-intent surgery.
Not a fit: Patients with advanced or metastatic cancer who are not candidates for curative surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve surgical precision and outcomes for patients with upper gastrointestinal cancers.
How similar studies have performed: Other studies using similar sentinel lymph node mapping techniques have shown promise, suggesting potential for success in this investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Adelaide, South Australia and 3 other locations
- Royal Adelaide Hospital — Adelaide, South Australia, Australia (Recruiting)
- Flinders Medical Centre — Bedford Park, South Australia, Australia (Recruiting)
- Austin Hospital — Heidelberg, Victoria, Australia (Not_yet_recruiting)
- Peter MacCallum Cancer Centre — Melbourne, Victoria, Australia (Not_yet_recruiting)
Study contacts
- Study coordinator: Markus Trochsler
- Email: Markus.Trochsler@sa.gov.au
- Phone: +61 08 82226750
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.