Plain English Summary
Background and study aims
Superparamagnetic iron oxide (SPIO) nanoparticles are a new tracer for the detection of breast cancer. Recent results have shown that injection of SPIO up to 4 weeks before surgery is feasible and increases detection rates. This is a very important advantage as it saves time during surgery. However, due to its paramagnetic properties, SPIO causes artefacts on MRI and if MRI has to be performed, it has to be done before the injection of SPIO. Skin staining is the most common side effect of SPIO injection. It has been shown to be related to the prolonged residence of the substance in the tissue, which is shown by the fact that stained tissue has a magnetic signal and that it is almost exclusively observed in breast conserving surgery. This is a matter of interest for patients who need to be followed up with MRI after surgery. The long lasting staining may pose a restriction as MRI will be contaminated by SPIO artefacts. Staining is significantly less if SPIO is injected deeply, near the tumour. The aim of this study is to confirm that, since the injected tissue and most of the SPIO are removed, there should not be any SPIO artefacts, or they should be much smaller.
Who can participate?
Women with breast cancer undergoing breast conserving surgery
What does the study involve?
After surgery, the background magnetic count is recorded. Skin staining and magnetic activity in the breast 2-3 weeks after the operation are recorded and the patients are followed up with an MRI scan 3 months after the operation. Depending on the present of artefacts, MRI follow up may be extended to 5 years after the operation.
What are the possible benefits and risks of participating?
Participants have a more frequent follow-up, but no other form of compensation or benefit. Taking part in the study has no risks for the patients, as breast MRI within the study is conducted without using intravenous paramagnetic contrast. The decision for contrast is made individually according to clinical indications.
Where is the study run from?
1. Uppsala University Hospital (Sweden)
2. Västmanland County Hospital (Sweden)
When is the study starting and how long is it expected to run for?
September 2017 to February 2023
Who is funding the study?
Uppsala University (Sweden)
Endomagnetics Ltd
Who is the main contact?
Dr Andreas Karakatsanis
Trial website
Contact information
Type
Scientific
Primary contact
Dr Andreas Karakatsanis
ORCID ID
http://orcid.org/0000-0003-3622-3575
Contact details
Uppsala University Hospital
Uppsala
751 85
Sweden
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The compatibility of POSToperative breast MRI in patients who underwent MAGnetic guided sentinel lymph node biopsy (POSTMAG MRI): a prospective study
Acronym
POSTMAG MRI
Study hypothesis
Superparamagnetic iron oxide (SPIO) nanoparticles are a novel tracer for the detection of sentinel node (SN) in patients with breast cancer. Apart from comparable performance of SPIO as a sole tracer to the dual standard, recent results have demonstrated that the preoperative injection of SPIO up to 4 weeks preoperatively in an outpatient basis is feasible and leads to enhancement of the detection rates, compared to the perioperative administration. This is a very important advantage, since it simplifies logistics and reduces operative time. However, due to its paramagnetic properties, SPIO causes artefacts on MRI and, if MRI has to be performed, it has to be done before the injection of SPIO.
Skin staining is the most common side effect of SPIO injection. It has been shown to be related to the prolonged residence of the substance in the tissue, a remark that is enhanced by the facts that stained tissue has a magnetic signal and that it is almost exclusively observed in breast conserving surgery (BCS). This is a matter of interest for patients who need to be followed postoperatively with MRI. Despite the fact that the indications are few, the long lasting staining may pose a restriction since MRI will be contaminated by SPIO artefacts. Peritumoral injection yields comparable SN detection rates and is connected with the presence of less staining, since the injected tissue is excised.
This prospective observational study will assess the compatibility of postoperative MRI in patients who have been injected peritumourally with SPIO for SN biopsy.
Hypothesis: Background counts on a magnetometer as well as skin discoloration correlate to the amount of SPIO residual in the tissue after breast conservation and therefore with the presence of artefacts on postoperative MRI in patients who underwent sentinel node biopsy for breast cancer with the use of SPIO.
Ethics approval
Ethics Committee Uppsala University, 20/07/2017, ref: DNR 2014/073 + 2014/073/1 + 2014/073/2
Study design
Multicentre observational longitudinal study.
Primary study design
Observational
Secondary study design
Longitudinal study
Trial setting
Hospitals
Trial type
Diagnostic
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Breast cancer
Intervention
Women undergoing BCS will take part in the study. After specimen excision, the background magnetic count will be registered. Postoperative skin staining and magnetic activity in the breast 2-3 weeks postoperatively will be registered and the patients will be followed with an MRI 3 months after the operation. Depending on the presence of artefacts, MRI follow-up may be extended to 5 years postoperatively.
Intervention type
Other
Phase
Drug names
Primary outcome measure
Magnetic signal in the breast and discoloration are registered intraoperatively, 1 and 3 months after surgery. If SPIO artefacts are seen on postoperative baseline MRI conducted 3 months after the operation, the patient will be followed up 6 months postoperatively and thereafter annually with controls as stated above up to 5 years postoperatively
Secondary outcome measures
Impact of different SPIO volumes on the prevalence of skin staining and MRI artefacts
Overall trial start date
01/09/2017
Overall trial end date
01/02/2023
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Patients with DCIS or T1 to T3 invasive breast cancer planned for BCS and SNB study
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
A minimum of 93
Participant exclusion criteria
1. Intolerance/hypersensitivity to iron or dextran compounds or Sienna XP
2. Patients with an iron overload disease
3. Patients with pacemakers or other implantable devices in the chest-wall, or prosthesis in the shoulder
4. Patient deprived of liberty or under guardianship
5. Pregnant or lactating patients
6. Intraoperative or postoperative conversion to mastectomy
7. Inability to provide informed consent
Recruitment start date
01/09/2017
Recruitment end date
01/09/2019
Locations
Countries of recruitment
Sweden
Trial participating centre
Uppsala University Hospital
751 85
Trial participating centre
Västmanland County Hospital
721 89
Sponsor information
Organisation
Uppsala University
Sponsor details
Uppsala University
Uppsala
751 05
Sweden
Sponsor type
University/education
Website
Funders
Funder type
University/education
Funder name
Uppsala Universitet
Alternative name(s)
Uppsala University
Funding Body Type
private sector organisation
Funding Body Subtype
Universities (academic only)
Location
Sweden
Funder name
Endomagnetics Ltd
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
The study protocol will be made available upon request to the investigators. Results are expected to be announced and published in a high-impact peer reviewed journal within a year after the completion of follow-up.
IPD sharing statement
The data sharing plans for the current study are unknown and will be made available at a later date.
Intention to publish date
01/02/2024
Participant level data
To be made available at a later date
Basic results (scientific)
Publication list