Magnetic Sentinel Lymph Node Mapping in Upper Gastro-Intestinal Cancer: A Feasibility Clinical Investigation
NCT ID: NCT05899985
Last Updated: 2025-08-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2024-03-21
2029-02-28
Brief Summary
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
Eligible subjects will undergo their normal standard of care treatment pathway with the added interventions described below.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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Royal Adelaide Hospital
OTHER
Austin Health
OTHER_GOV
Flinders Medical Centre
OTHER_GOV
Peter MacCallum Cancer Centre, Australia
OTHER
South Australian Health and Medical Research Institute
OTHER
Ferronova Pty Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Joe El-Aklouk
Role: STUDY_DIRECTOR
Ferronova Pty Ltd
Locations
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Royal Adelaide Hospital
Adelaide, South Australia, Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia
Austin Hospital
Heidelberg, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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SMF-3
Identifier Type: -
Identifier Source: org_study_id
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