Breast Cancer
Conditions
Keywords
Magtrace, MRI, Mammography
Brief summary
Rationale: MagTrace® will be implemented as standard of care for sentinel lymph node biopsy, since it has several advantages compared to a radioactive technique. However, MagTrace® is known to interfere with MRI during follow-up imaging when using 2 mL. No data is available for patients who received 1 mL of MagTrace®, as is described in our current protocol. A contrast enhanced mammography (CEM) could be an alternative for MRI if it still shows artefacts. Objective: The primary objective in this trial is to evaluate the use of MRI and contrast enhanced mammography after using MagTrace® to perform a sentinel node biopsy. Study design: Prospective trial in an outpatient clinic setting. Study population: Patients who were included in the previous MagTrace study will be asked to participate in this subsequent trial. Study procedure: Participants will undergo MRI and CEM as standard 1-year follow-up. Since the MagTrace study started in August 2021 and finished in February 2022, this trial will start August 2022 to February 2023. Main study parameters/endpoints: To evaluate the use of MRI and CEM, the following primary endpoints will be assessed: Visibility and size of artefacts undergoing MRI and CEM and its consequences of the quality for image assessment. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Since MagTrace® will be implemented as standard localisation technique for breast conserving surgery and sentinel lymph node biopsy in Zuyderland MC, the information obtained from this trial is essential for the follow-up planning of all breast cancer patients. Therefore, the burden for the patients (undergoing extra imaging) will be in proportion to the added value of this trial.
Interventions
DIAGNOSTIC_TESTMRI
Patients will undergo an MRI and mammography one year after MagTrace injections
Sponsors
Zuyderland Medisch Centrum
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Female patients of 18 years and older. * Previously underwent sentinel lymph node biopsy using MagTrace®. * Undergoing standard follow-up for previous breast cancer
Exclusion criteria
* Unable to comprehend the extend and implications of the study and sign for informed consent. * Standard MRI
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Are there any artefacts visible when undergoing an MRI? | One year after surgery | Visible artefacts on MRI |
| Are there any artefacts visible when undergoing a CEM? | One year after surgery | Visible artefacts on CEM |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Size of the possible artefact. | One year after surgery | Size of the artefacts on MRI and mammography |
| The possibility to assess the imaging by a trained radiologist | One year after surgery | The radiologist will score the assessability using a 4 point scoring system: 0\. No artefact 1. Good diagnostic quality 2. Impaired but still readable 3. Hampered clinical assessment |
Contacts
Primary ContactMerel Spiekerman van Weezelenburg, MD
Backup ContactYvonne Vissers, MD, PhD
Outcome results
None listed