The primary objective in this trial is to evaluate the use of MRI and contrast enhanced mammography after using MagTrace® to perform a breast conserving surgery and a sentinel node biopsy.
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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.
Secondary outcome
n/a.
Background summary
MagSeed® and MagTrace® will be implemented as standard of care for breast
conserving surgery and 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.
Study objective
The primary objective in this trial is to evaluate the use of MRI and contrast
enhanced mammography after using MagTrace® to perform a breast conserving
surgery and a sentinel node biopsy.
Study design
Prospective trial in an outpatient clinic setting.
Study burden and risks
Since MagTrace® and MagSeed® 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.
Dr. H. van der Hoffplein 1
Geleen 6162 BG
NL
Dr. H. van der Hoffplein 1
Geleen 6162 BG
NL
Listed location countries
Age
Inclusion criteria
- Female patients of 18 years and older.
- Previously underwent breast conserving surgery and 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:
o Implantable (electrical) devices (e.g., pacemaker, cochlear implants,
neurostimulator);
o Any other metal implants;
o Claustrophobia;
o MR-incompatible prosthetic heart valves.
- Standard CEM exclusion criteria:
o Breast implants.
NB: since no contrast will be used during the CEM, standard contrast
contraindications were not included as exclusion criteria for this trial.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL82061.096.22 |