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

Breast Cancer Clinical Trial

— MagTrace2  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05637528
• Other study ID #: NL82061.096.22
• Status: Not yet recruiting
• Start date: November 23, 2022
• Est. completion date: March 31, 2023

Study information

• Verified date: November 2022
• Source: Zuyderland Medisch Centrum
• Contact: Merel Spiekerman van Weezelenburg, MD
• Phone: 088 459 7777
• Email: m.spiekermanvanweezelenburg[@]zuyderland.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: March 31, 2023
• Est. primary completion date: February 23, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Diagnostic Test:
• MRI
Patients will undergo an MRI and mammography one year after MagTrace injections

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Zuyderland Medisch Centrum

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Are there any artefacts visible when undergoing an MRI?	Visible artefacts on MRI	One year after surgery
Primary	Are there any artefacts visible when undergoing a CEM?	Visible artefacts on CEM	One year after surgery
Secondary	Size of the possible artefact.	Size of the artefacts on MRI and mammography	One year after surgery
Secondary	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