FDA clears lymph node biopsy system for metastatic breast cancer detection

FDA clears lymph node biopsy system for metastatic breast cancer detection

by John R. Fischer, Senior Reporter | July 26, 2018
Medical Devices

The FDA evaluated the system using a coordinated, cross-agency approach and data retrieved from a trial of 147 breast cancer patients, comparing its efficiency to that of injections of blue dye and radioactive materials.

All patients underwent both methods with the Sentimag System scoring a 94.3 percent rate for lymph node detection, compared to injections, which scored 93.5 percent. An overall 98 percent of patients had the same rate of detection with both.

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The use of Magtrace adds sentinel node detection capability to the Magseed lesion localization marker that has been available in the U.S. for two years. The system can also be used to localize primary cancer while locating sentinel nodes, allowing hospitals to reduce radiation exposure, increase patient convenience, and further simplify workflow.

“Magtrace is truly unique, in that it is the only tracer in the world that can be injected days before the surgery, without marking any higher echelon nodes. This not only improves scheduling and the patient experience, it also allows the surgeons to carry out new techniques, such as a delayed sentinel node biopsy for patients with DCIS undergoing a mastectomy. This has the potential to spare the patient the need for an unnecessary intervention in the axilla that is of no benefit to them.”

The injection of Magtrace directly into the bloodstream may steer it away from injection sites such as the liver or spleen, causing image artifacts to appear during MR exams. This effect has not been reported in X-ray, PET, CT, PET/CT or ultrasound imaging studies.

It should also be noted that the Sentimag System is contraindicated in any patient with hypersensitivity to iron oxide or dextran compounds, and is not recommended for those with iron overload disease or metal implants in the axilla or chest.

The most common adverse event found during the study was breast discoloration in patients who underwent mastectomies, suffer from bradycardia or had potential allergic reactions to the magnetic materials. The effect was reported to have disappeared three months later.

The clinical review was conducted by the FDA’s CDRH alongside the Center for Drug Evaluation and Research, and with the support of the FDA’s Oncology Center for Excellence. All other aspects of the review and final product approval were carried out by the FDA’s CDRH.

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