Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000687897
Ethics application status
Approved
Date submitted
11/04/2021
Date registered
4/06/2021
Date last updated
6/06/2023
Date data sharing statement initially provided
4/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Magnetic Sentinel Lymph Node Mapping with FerroTrace in Breast Cancer: A Feasibility and Validity Clinical Trial
Scientific title
Magnetic Sentinel Lymph Node Mapping with FerroTrace in Breast Cancer: A Feasibility and Validity Clinical Trial
Secondary ID [1] 303501 0
SMF-1
Universal Trial Number (UTN)
U1111-1265-0782
Trial acronym
MAGSENT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast cancer 320825 0
Condition category
Condition code
Cancer 318650 318650 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a single centre, open label, side-by-side comparator study to assess the feasibility and validity of using FerroTrace for mapping sentinel lymph nodes (SLNs) in subjects diagnosed with breast cancer, and to investigate clearance of the tracer from the injection site. A maximum of 20 subjects will be enrolled. Eligible subjects will receive both a single 0.4-0.5ml surgeon injected dose of FerroTrace and a single radiologist injected dose of Technetium (99mTc) antimony sulphide colloid via intraparenchymal injections into the breast tissue the day prior to, or on the morning of, surgery. During surgery, a modified sentinel lymph node biopsy (SLNB) will be performed, using a magnetometer probe to locate the magnetic tracer in sentinel nodes, followed by the standard gamma probe to locate the Technetium (99mTc) antimony sulphide colloid. To assess tracer clearance, at least one follow-up MRI of the breast will be performed 30 days after surgery, with additional MRIs at 90 days and 180 days after surgery if there is not complete clearance on the earlier post-operative MRI.
Intervention code [1] 319788 0
Treatment: Surgery
Intervention code [2] 319789 0
Treatment: Devices
Comparator / control treatment
Intraparenchymal or peri-tumoural injection of radioisotope according to standard protocols (Technetium (99mTc) antimony sulphide colloid), lymphoscintigraphy as per standard nuclear medicine protocols for breast cancer lymph node mapping, optional SPECT/CT where the lymphoscintigraphy is inconclusive, and intra-operative detection of the radioisotope with a gamma probe.
Control group
Active

Outcomes
Primary outcome [1] 326597 0
Impact of FerroTraceTM particles at the injection site on breast MRI (time frame: 30 days, with follow-ups at 90 days and 180 days if required).
Timepoint [1] 326597 0
30 days, with follow-ups at 90 days and 180 days if required).
Secondary outcome [1] 392046 0
Composite outcome : Safety- Percentage of subjects with adverse events overall, by severity and relatedness.
Assessed according to the Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0
Timepoint [1] 392046 0
Enrolment to 30 days post surgery
Secondary outcome [2] 392047 0
Composite outcome: Number of sentinel lymph nodes identified with the FerroTrace and standard radioisotope methods, and concordance (number and pathology).
Assessed by the number of nodes identified during surgery (biopsy) and the assessment of those nodes by histopathology
Timepoint [2] 392047 0
Surgery (day 0) and followup (day 14)

Eligibility
Key inclusion criteria
1. Subject is capable of understanding, and willing to provide, written informed consent.
2. Female between 18 and 75 years of age (inclusive) at the time of providing informed consent.
3. Subject with a confirmed diagnosis of primary breast cancer.
4. Subject is scheduled for lumpectomy and an SLNB procedure as part of the surgical plan.
5. Subject has a clinical negative node status (i.e., cN0) at the time of providing informed consent.
6. Pre-menopausal subjects must be willing to use methods of contraception as deemed adequate by the Investigator to be eligible for, and continue participation in, the study.
7. Subject has had contrast-enhanced mammography showing no, minimal, or mild background parenchymal enhancement.
8. In the opinion of the Investigator, the subject can complete the study in compliance with the protocol and is able to comply with the requirements of the study protocol.
9. Subjects with an ECOG performance status of Grade 0–2.
Minimum age
18 Years
Maximum age
75 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Subject has had preoperative radiation therapy to the affected breast or axilla.
2. Subject has received a Feraheme® (ferumoxytol) injection within the past 180 days.
3. Subject has a known history of allergies, hypersensitivity, or intolerances as follows:
a. Iron compounds
b. Polyacrylamide
c. PEG
d. Known or suspected hypersensitivity to the investigational product, or to any ingredients of the investigational product.
4. Subject known to have haemochromatosis
5. Subject has a co-morbid condition with an estimated life expectancy of <180 days at the time of consent.
6. Subjects who are pregnant, trying to fall pregnant in prior 14 days, or lactating at time of screening.
7. Subject has participated in another investigational drug study within 30 days of scheduled surgery.
8. Subject has one or more absolute contraindications to MRI scanning as per Investigator judgement.
9. Subject has had contrast-enhanced mammography showing moderate or marked background parenchymal enhancement.
10. Subject has a genetic mutation or family history of breast/ovarian cancer such that MRI is recommended as a screening modality.
11. Subjects with an eGFR of < 30 ml/min/1.73m2.
12. Subject has a metallic implant of any type in the chest wall, including pacemakers and implantable defibrillators.
13. Subject has inability or unwillingness to comply with all follow-up 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.
14. Investigator determines that the subject is not suitable for study participation for any other reason (e.g., Subject has had previous axilla surgery, or lymphatic function that is impaired in the surgeon’s judgment).

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
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
Safety/efficacy
Statistical methods / analysis
Sample Size Justification
The sample size of 20 subjects is calculated based on acquiring a statistically significant number of subjects who complete the study, given the minimum success measure of 70% of subjects achieving MRIs at 180 days with no magnetic artefacts (30% toxicity rate), and an expected success rate of 95% (5% toxicity rate based on animal clearance studies).

16 subjects are required to decide whether the proportion failing, P, is = 0.050 or = 0.300. If the number of responses is 3 or more, the hypothesis that P = 0.050 is rejected with a target error rate of 0.050 (alpha) and an actual error rate of 0.043. If the number of responses is 2 or less, the hypothesis that P = 0.300 is rejected with a target error rate of 0.100 and an actual error rate of 0.099 (beta). Assuming a drop-out rate of 20%, 20 subjects will be enrolled.

Analysis Plan
The efficacy analysis will be based on the comparison of lymph node localisation using the FerroTrace and SentiMag® handheld magnetic probe (test) versus the radioisotope and gamma probe (control).

The total number of nodes detected/not detected with the test and control will be cross-tabulated. The per node lymph node detection rate (%) for the test and control will be calculated as the total number of nodes detected by the test/control out of the total number of nodes, expressed as a percentage. The per node discordance rate (%) will be calculated as the sum of the lymph nodes detected by only the test or only the control out of the total number of nodes, expressed as a percentage. The per subject lymph node detection rate (%) for the test and control will be calculated as the total number of subjects with at least one node detected by the test/control out of the total number of subjects with at least one detected node, expressed as a percentage. The per subject lymph node concordance rate (%) will be calculated as the total number of subjects with a lymph node detected by both the test and control out of the overall number of subjects with at least one detected lymph node, expressed as a percentage. The per subject lymph node discordance rate (%) will be calculated as the sum of the subjects with at least one lymph node detected by only the test or only the control out of the total number of subjects with at least one detected lymph node, expressed as a percentage.

The number of nodes per subject will also be summarised using descriptive statistics.

The per node and per subject analyses will also be repeated for metastatic nodes.
All collected data will be included in the data listings.

Recruitment
Recruitment status
Stopped early
Data analysis
No data analysis planned
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
14/06/2021
Actual
29/07/2021
Date of last participant enrolment
Anticipated
31/12/2022
Actual
30/07/2021
Date of last data collection
Anticipated
30/06/2023
Actual
Sample size
Target
20
Accrual to date
Final
2
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 18757 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 33201 0
3050 - Parkville

Funding & Sponsors
Funding source category [1] 307918 0
Commercial sector/Industry
Name [1] 307918 0
Ferronova Pty Ltd
Country [1] 307918 0
Australia
Primary sponsor type
Commercial sector/Industry
Name
Ferronova Pty Ltd
Address
MM Building, University of South Australia
Mawson Lakes Blvd
Mawson Lakes SA 5095
Country
Australia
Secondary sponsor category [1] 308631 0
None
Name [1] 308631 0
Address [1] 308631 0
Country [1] 308631 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307916 0
Melbourne Health Human Research Ethics Committee
Ethics committee address [1] 307916 0
Ethics committee country [1] 307916 0
Australia
Date submitted for ethics approval [1] 307916 0
24/02/2021
Approval date [1] 307916 0
31/03/2021
Ethics approval number [1] 307916 0
HREC/73027/MH-2021

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

Contacts
Principal investigator
Name 108918 0
Prof Gregory Bruce Mann
Address 108918 0
Suite 12, Royal Womens Hospital
300 Grattan Street, Parkville VIC 3052
Country 108918 0
Australia
Phone 108918 0
+61 3 9347 6301
Fax 108918 0
Email 108918 0
[email protected]
Contact person for public queries
Name 108919 0
Gregory Bruce Mann
Address 108919 0
Suite 12, Royal Womens Hospital
300 Grattan Street, Parkville VIC 3052
Country 108919 0
Australia
Phone 108919 0
+61 3 9347 6301
Fax 108919 0
Email 108919 0
[email protected]
Contact person for scientific queries
Name 108920 0
Gregory Bruce Mann
Address 108920 0
Suite 12, Royal Womens Hospital
300 Grattan Street, Parkville VIC 3052
Country 108920 0
Australia
Phone 108920 0
+61 3 9347 6301
Fax 108920 0
Email 108920 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
De-identified data will be available to the Sponsor and Investigators to enable publication, or as part of any regulatory requirements. It will not be available other than for these purposes.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.