U.K. cancer care technology developer Endomag said that a pivotal clinical trial is underway in the U.S. for its Sentimag and Sienna+ magnetic detection system, which is designed to stage breast cancer during sentinel lymph node biopsy procedures.
After injecting the Sienna+ magnetic tracer into the patient's breast, surgeons use the Sentimag handheld probe to locate sentinel nodes that have taken up the tracer, according to the firm. The system avoids the use of radioisotopes traditionally used in cancer staging, Endomag said.
The clinical trial, which is being led by the University of California, San Francisco, and five other U.S. sites such as MD Anderson Cancer Center, will enroll up to 180 breast cancer patients. The goal is to provide further clinical evidence that the Sentimag and Sienna+ system is as safe and effective as the current standard of care, Endomag said.
The firm received an investigational device exemption (IDE) from the U.S. Food and Drug Administration (FDA) in December. The system has been approved for use in Europe since 2012.
