The primary objective of this study is to determine the competence of a magnetic marker as a technique to localise non-palpable breast cancer, measured through retrieval rate using only the magnetic probe. The secondary objectives of this study are…
ID
Source
Brief title
Condition
- Miscellaneous and site unspecified neoplasms benign
- Breast therapeutic procedures
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Data regarding the retrieval rate of the magnetic marker will be collected
peri-operatively, using the magnetic probe to confirm the marker present in the
excised tissue and to confirm the marker absent in the patients.
Postoperatively, a pathologist will confirm the presence of the marker in the
excised tissue.
Secondary outcome
Data regarding the resection margins will be collected from the pathology
report.
Data with respect to radiologist and surgeon satisfaction will be measured
through the questionnaires presented in appendix 2.
During the intake session, before the radiological intervention, patient
demographics and relevant medical data will be registered, regarding the age of
the patient, the location of the tumour (left or right breast, quadrant of the
breast), histological aspects of the tumour (type, grade, size) and time
between marker placement and surgery.
Background summary
When conducting breast-conserving surgery, accurate tumour localisation is
challenging when the tumour is not palpable. Existing techniques for tumour
localisation, such as wire guided and radioactive seed localisation yield
acceptable results but have considerable disadvantages, like organisational and
legislative aspects and high patient discomfort. Recently, a new technique has
been developed to overcome these issues; localisation through a magnetic marker
and probe.
Study objective
The primary objective of this study is to determine the competence of a
magnetic marker as a technique to localise non-palpable breast cancer, measured
through retrieval rate using only the magnetic probe. The secondary objectives
of this study are (I) to assess the resection margins and (II) to assess
radiologist and surgeon satisfaction.
Study design
A prospective cohort pilot study.
Intervention
Radiological intervention
All patients will receive a radioactive iodine seed (Bard Medical, Covington,
USA) as per standard care, and the experimental magnetic marker (Magseed
marker, Sysmex Europe GmbH). A radiologist will implant both markers under
ultrasonic guidance in the same session. After implantation, the accuracy of
location will be assessed through mammography.
Surgical intervention
The surgery will be performed within 30 days of implantation. During the
surgery, the magnetic probe (Sentimag Probe, Sysmex Europe GmbH) will be
available for localising the marker. Polymer tools will be provided as to not
interfere with the magnetic probe. The gamma probe (Neoprobe, Mammotome,
Cincinnati, USA) will be available, however, it will only be used as a back-up
for when localisation through the magnetic probe is not possible or when the
surgeon feels unsure about the location determined with the magnetic probe.
Post-operatively, patients will receive standard follow-up care.
Study burden and risks
Implanting one extra marker in addition to the standard care marker, implanted
through the same incision, without extra time or risk for the patient.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
I. Female patients aged 18 years or older;
II. Patients have biopsy-confirmed, unifocal, non-palpable breast cancer;
III. Patients are eligible for breast-conserving surgery;
IV. Patients did not undergo any neo-adjuvant treatment;
Exclusion criteria
Patients do not have a pacemaker.
Design
Recruitment
Medical products/devices used
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL65259.058.18 |