Magnetic marker localisation for non-palpable breast cancer.

Magnetic marker localisation for non-palpable breast cancer. - Magnetic marker localisation

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON48788

Enrollment

Registered

2019-04-11

Start date

2019-10-15

Completion date

Unknown

Last updated

2024-04-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

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

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Patients do not have a pacemaker.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)