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

Evaluating the use of Magnetic Resonance Imaging and Contrast Enhanced Mammography after MagTrace® use - MagTrace 2

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON51366

Enrollment

Registered

2022-09-21

Start date

2022-08-01

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer mammacarcinoma

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
n/a.	—

Countries

Netherlands

Outcome results