Evaluating the Use of Magnetic Resonance Imaging and Contrast Enhanced Mammography After MagTrace® Use

Study Overview
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Brief Summary
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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.

Official Title
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Evaluating the Use of Magnetic Resonance Imaging and Contrast Enhanced Mammography After MagTrace® Use

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: MRI


Participation Criteria
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Eligibility Criteria
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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 exclusion criteria: Implantable (electrical) devices (e.g., pacemaker, cochlear implants, neurostimulator); Any other metal implants; Claustrophobia; MR-incompatible prosthetic heart valves. Standard CEM exclusion criteria: Breast implants.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MagTrace patients<br>Patients who underwent sentinel lymph node biopsy with MagTrace one year ago. | Diagnostic Test: MRI<br>* Patients will undergo an MRI and mammography one year after MagTrace injections<br>* Other names: Mammography;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Are there any artefacts visible when undergoing an MRI? | Visible artefacts on MRI | One year after surgery | 
| Are there any artefacts visible when undergoing a CEM? | Visible artefacts on CEM | One year after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of the possible artefact. | Size of the artefacts on MRI and mammography | One year after surgery | 
| The possibility to assess the imaging by a trained radiologist | The radiologist will score the assessability using a 4 point scoring system: 0. No artefact Good diagnostic quality Impaired but still readable Hampered clinical assessment | One year after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MRI, Magtrace, Mammography