Magnetic Tracer in the Sentinel Node Procedure in Breast Cancer: the Non-radioactive Alternative for Radio-isotopes

  • STATUS
    Recruiting
  • days left to enroll
    31
  • participants needed
    40
  • sponsor
    Zuyderland Medisch Centrum
Updated on 24 November 2021
sentinel node
breast-conserving surgery

Summary

Rationale

In breast cancer, a sentinel node procedure is performed to investigate whether malignant cells have spread to the axillary lymph nodes. This is an important part of determining the stage of breast cancer and the final treatment plan.

A disadvantage of the sentinel node procedure is that it is performed using radioactive tracing with concomitant radiation exposure for the patients and involved health care personnel. In addition, the use of radioactive tracing puts high demands on the logistics in the operation theatre: the capacity of patients that can be treated in one day is limited and the radio-active tracing leads to many time-consuming precautionary measures.

A radiation free alternative would therefore have multiple advantages. Not only with respect to radiation exposure for the patients and health care workers, but also by reducing the waiting time for operation for the patients as it will make the planning of patients for surgery more efficient.

Recently, a radiation free tracer for the sentinel node procedure has become available (Magtrace). This tracer has been tested in small-case studies and is currently used as standard care in several hospitals around the world.

Objective

The primary objective of this study is to evaluate the diagnostic accuracy of Magtrace in the sentinel node procedure in breast cancer in the Breast Care Centre in Zuyderland Medical Centre; with the ultimate goal to make the sentinel node procedure a radiation free process.

Study design:

A prospective cohort of forty patients with breast cancer and an indication for a sentinel node procedure will be injected with both Technetium (radioisotope) and Magtrace (magnetic). All patients in this study will receive both tracers.

Study population:

Patients of 18 years or older with breast cancer and an indication for a sentinel node procedure will be included. These patients will be recruited by their breast surgeon in the outpatient department of the Breast Care Centre in Zuyderland Medical Centre.

Intervention (if applicable):

Sentinel node procedure using a magnetic tracer next to Technetium.

Main study parameters/endpoints:

The concordance in detection of sentinel nodes by Magtrace and the Technetium tracer, measured by the sensitivity and specificity of Magtrace in detecting sentinel nodes with Technetium tracer as gold standard.

Nature and extent of the burden and risks associated with participation, benefit and group

relatedness

The goal of this project is evaluating the diagnostic accuracy of Magtrace in the sentinel node procedure. To establish that Magtrace is a non-inferior and a non-radioactive alternative for Technetium with respect to reliability in detecting metastases. The ultimate goal is to make the sentinel node procedure a radiation free process.

Details
Condition Breast Cancer, breast carcinoma, cancer, breast, Breast Cancer Diagnosis
Treatment MagSeed and MagTrace in breast cancer patiënts
Clinical Study IdentifierNCT05122585
SponsorZuyderland Medisch Centrum
Last Modified on24 November 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Female patient of 18 years or older
Patient with breast cancer and indication for sentinel node procedure

Exclusion Criteria

Patients with a previous history of the sentinel node procedure or axillary lymph node dissection in the unilateral breast
Unable to comprehend implications and extent of study and sign for informed consent
Known allergy or hypersensitivity to iron oxide or dextran
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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