Evaluating the Use of Magnetic Resonance Imaging and Contrast Enhanced Mammography After MagTrace® Use (MagTrace2)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Diagnostic test: MRI

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Merel Spiekerman van Weezelenburg, MD; Phone Number: 088 459 7777; Email: m.spiekermanvanweezelenburg@zuyderland.nl
• Study Contact Backup: Name: Yvonne Vissers, MD, PhD; Phone Number: 088 459 7777; Email: y.vissers@zuyderland.nl

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patients who participated in the previous MagTrace study will be included. All patients will be approached before their 1-year follow-up appointment at the radiology department. Patients will be informed by telephone by the coordinating investigator. If they are interested in this study, the patients will receive the patient information folder. Forty patients were included in the MagTrace study, so depending on the participants' willingness to participate in this subsequent trial, up to 40 patients will participate.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
MagTrace patients; Patients who underwent sentinel lymph node biopsy with MagTrace one year ago.	Diagnostic test: MRI; Patients will undergo an MRI and mammography one year after MagTrace injections; Other Names: Mammography

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zuyderland Medisch Centrum

Study record dates

Study Major Dates

• Study Start (Anticipated): November 23, 2022
• Primary Completion (Anticipated): February 23, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: November 23, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: MRI; Mammography; Magtrace
• Other Study ID Numbers: NL82061.096.22

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No