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

NCT05637528 | Unknown DMC

• 1 other identifier: NL82061.096.22
• Study Type: observational
• Target: 25
• Locations: 0 countries
• Sites: N/A

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

Keywords

Magtrace; MRI; Mammography

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Size of the possible artefact.

  One year after surgery

• The possibility to assess the imaging by a trained radiologist

  One year after surgery

Study Arms (1)

MagTrace patients

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

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

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

Also known as: Mammography

MagTrace patients

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Female patients of 18 years and older.
• Previously underwent sentinel lymph node biopsy using MagTrace®.
• Undergoing standard follow-up for previous breast cancer

You may not qualify if:

• 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.

Sponsors & Collaborators

• Zuyderland Medisch Centrum: lead

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Mammography

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Merel Spiekerman van Weezelenburg, MD

CONTACT

088 459 7777; m.spiekermanvanweezelenburg@zuyderland.nl

Yvonne Vissers, MD, PhD

CONTACT

088 459 7777; y.vissers@zuyderland.nl

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 5, 2022
• Study Start: November 23, 2022
• Primary Completion: February 23, 2023
• Study Completion: March 31, 2023
• Last Updated: December 5, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share