Magnetic Sentinel Lymph Node Mapping in Upper Gastro-Intestinal Cancer: A Feasibility Clinical Investigation
Condition(s) studied
Investigational drug(s) / intervention(s)
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
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.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Royal Adelaide Hospital | Adelaide | South Australia | |
| Flinders Medical Centre | Bedford Park | South Australia | |
| Austin Hospital | Heidelberg | Victoria | |
| Peter MacCallum Cancer Centre | Melbourne | Victoria |
Other trials for the same condition
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.
View NCT05899985 on ClinicalTrials.gov ↗ ← All trials in Australia