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

NCT ID: NCT05637528

Last Updated: 2022-12-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 25 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-23
• Study Completion Date: 2023-03-31

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

MagTrace patients

Patients who underwent sentinel lymph node biopsy with MagTrace one year ago.

MRI

Intervention Type: DIAGNOSTIC_TEST

Patients will undergo an MRI and mammography one year after MagTrace injections

Interventions

MRI

Patients will undergo an MRI and mammography one year after MagTrace injections

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

Mammography

Eligibility Criteria

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.

• Implantable (electrical) devices (e.g., pacemaker, cochlear implants, neurostimulator);
• Any other metal implants;
• Claustrophobia;
• MR-incompatible prosthetic heart valves.

• Breast implants.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Zuyderland Medisch Centrum

OTHER

Sponsor Role: lead

Responsible Party

Yvonne Vissers

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Merel Spiekerman van Weezelenburg, MD

Role: CONTACT

m.spiekermanvanweezelenburg@zuyderland.nl

088 459 7777

Yvonne Vissers, MD, PhD

Role: CONTACT

y.vissers@zuyderland.nl

088 459 7777

Other Identifiers

NL82061.096.22

Identifier Type: -

Identifier Source: org_study_id