Trial Title:
Magnetic Sentinel Lymph Node Mapping in Upper Gastro-Intestinal Cancer: A Feasibility Clinical Investigation
NCT ID:
NCT05899985
Condition:
Gastric Cancer
Esophageal Cancer
Conditions: Official terms:
Intestinal Neoplasms
Gastrointestinal Neoplasms
Conditions: Keywords:
Sentinel lymph node
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Intervention model description:
Multi-centre, partially blinded, side-by-side comparator study
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) System
Description:
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).
Arm group label:
Single Arm
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.
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.
Criteria for eligibility:
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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Royal Adelaide Hospital
Address:
City:
Adelaide
Zip:
5000
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Bernadette Swart
Phone:
+61 8 71172209
Email:
Health.CALHNResearchGovernance@sa.gov.au
Investigator:
Last name:
Markus Trochsler, MD
Email:
Principal Investigator
Facility:
Name:
Flinders Medical Centre
Address:
City:
Bedford Park
Zip:
5042
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Kerrie Freeman
Phone:
+61 8 8204 6061
Email:
Health.SALHNOfficeforResearch@sa.gov.au
Investigator:
Last name:
David Watson, MD
Email:
Principal Investigator
Facility:
Name:
Austin Hospital
Address:
City:
Heidelberg
Zip:
3084
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Sianna Panagiotopoulos
Phone:
+61 3 94964090
Email:
ethics@austin.org.au
Investigator:
Last name:
David Liu, MD
Email:
Principal Investigator
Facility:
Name:
Peter MacCallum Cancer Centre
Address:
City:
Melbourne
Zip:
3000
Country:
Australia
Status:
Not yet recruiting
Contact:
Last name:
Dianne Snowden
Phone:
+61 3 85597540
Email:
ethics@petermac.org
Investigator:
Last name:
David Liu, MD
Email:
Principal Investigator
Start date:
March 21, 2024
Completion date:
February 2030
Lead sponsor:
Agency:
Ferronova Pty Ltd
Agency class:
Industry
Collaborator:
Agency:
Royal Adelaide Hospital
Agency class:
Other
Collaborator:
Agency:
Austin Health
Agency class:
Other
Collaborator:
Agency:
Flinders Medical Centre
Agency class:
Other
Collaborator:
Agency:
Peter MacCallum Cancer Centre, Australia
Agency class:
Other
Collaborator:
Agency:
South Australian Health and Medical Research Institute
Agency class:
Other
Source:
Ferronova Pty Ltd
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05899985
