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Trial Title:
Evaluating the Use of Magnetic Resonance Imaging and Contrast Enhanced Mammography After MagTrace® Use
NCT ID:
NCT05637528
Condition:
Breast Cancer
Conditions: Keywords:
Magtrace
MRI
Mammography
Study type:
Observational
Overall status:
Unknown status
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
MRI
Description:
Patients will undergo an MRI and mammography one year after MagTrace injections
Arm group label:
MagTrace patients
Other name:
Mammography
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
- 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Start date:
November 23, 2022
Completion date:
March 31, 2023
Lead sponsor:
Agency:
Zuyderland Medisch Centrum
Agency class:
Other
Source:
Zuyderland Medisch Centrum
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05637528
