Evaluating the use of Magnetic Resonance Imaging and Contrast Enhanced Mammography after MagTrace® use

• Conditions: breast cancer; mammacarcinoma; 10006291

• Registration Number: NL-OMON51366
• Lead Sponsor: Zuyderland Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 9 April 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 40

Inclusion Criteria

- Female patients of 18 years and older.
- Previously underwent breast conserving surgery and 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:
o Implantable (electrical) devices (e.g., pacemaker, cochlear implants,
neurostimulator);
o Any other metal implants;
o Claustrophobia;
o MR-incompatible prosthetic heart valves.
- Standard CEM exclusion criteria:
o Breast implants.
NB: since no contrast will be used during the CEM, standard contrast
contraindications were not included as exclusion criteria for this trial.

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>To evaluate the use of MRI and CEM, the following primary endpoints will be<br /><br>assessed: Visibility and size of artefacts undergoing MRI and CEM and its<br /><br>consequences of the quality for image assessment. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>n/a. </p><br>