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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05899985




Registration number
NCT05899985
Ethics application status
Date submitted
2/06/2023
Date registered
12/06/2023

Titles & IDs
Public title
Magnetic Sentinel Lymph Node Mapping in Upper Gastro-Intestinal Cancer: A Feasibility Clinical Investigation
Scientific title
Magnetic Sentinel Lymph Node Mapping in Upper Gastro-Intestinal Cancer: A Feasibility Clinical Investigation
Secondary ID [1] 0 0
SMF-3
Universal Trial Number (UTN)
Trial acronym
MAGMAP
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastric Cancer 0 0
Esophageal Cancer 0 0
Condition category
Condition code
Cancer 0 0 0 0
Bowel - Back passage (rectum) or large bowel (colon)
Cancer 0 0 0 0
Bowel - Small bowel (duodenum and ileum)
Cancer 0 0 0 0
Other cancer types
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - FerroTrace® and FerroMag Sentinel Lymph Node Mapping (SLNM) System

Other: Single Arm - Eligible subjects will undergo their normal standard of care treatment pathway with the added interventions described below.


Other interventions: 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).
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
SLN detection rate
Timepoint [1] 0 0
Up to 14 days post surgery
Primary outcome [2] 0 0
Ultra-staging diagnostic value
Timepoint [2] 0 0
Up to 14 days post surgery
Primary outcome [3] 0 0
Surgical quality
Timepoint [3] 0 0
Up to 14 days post surgery
Secondary outcome [1] 0 0
Rate of Adverse Events (AEs)
Timepoint [1] 0 0
The earlier of 28 days post FerroTrace injection or commencement of neoadjuvant therapy or surgery
Secondary outcome [2] 0 0
SLN Location Disease Free Survival
Timepoint [2] 0 0
Up to 5 years post surgery
Secondary outcome [3] 0 0
SLN Ultra-staging Disease Free Survival
Timepoint [3] 0 0
Up to 5 years post surgery
Secondary outcome [4] 0 0
SLN Location Overall Survival
Timepoint [4] 0 0
Up to 5 years post surgery
Secondary outcome [5] 0 0
SLN Ultra-staging Overall Survival
Timepoint [5] 0 0
Up to 5 years post surgery

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/03/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/02/2030
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
Austin Hospital - Heidelberg
Recruitment hospital [4] 0 0
Peter MacCallum Cancer Centre - Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
3000 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Ferronova Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Royal Adelaide Hospital
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Government body
Name [2] 0 0
Austin Health
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Government body
Name [3] 0 0
Flinders Medical Centre
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Other
Name [4] 0 0
Peter MacCallum Cancer Centre, Australia
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
South Australian Health and Medical Research Institute
Address [5] 0 0
Country [5] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Joe El-Aklouk
Address 0 0
Ferronova Pty Ltd
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Markus Trochsler
Address 0 0
Country 0 0
Phone 0 0
+61 08 82226750
Fax 0 0
Email 0 0
Markus.Trochsler@sa.gov.au
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05899985