The study is being led by the University of California San Francisco and five other sites across the US, including MD Anderson Cancer Center, and will enrol up to 180 breast cancer patients. This pivotal trial follows the December approval of Endomag’s Investigational Device Exemption (IDE) by the United States Food and Drug Administration (FDA).
The Sentimag® and Sienna+® magnetic detection system is used during cancer staging in the Sentinel Lymph Node Biopsy (SLNB) procedure, and allows surgeons to locate the lymph nodes that potentially harbour cancer with unprecedented sensitivity and accuracy.
To use the system, surgeons inject the Sienna+® magnetic tracer into the breast and then use the Sentimag® handheld probe to find the sentinel nodes that have taken up the Sienna+®.
"This product has the potential to eliminate radioisotopes in sentinel node biopsy, simplifying the procedure for surgeons and making accurate staging more widely available."
The Endomag system avoids the radioisotopes traditionally used in cancer staging, offers patients a pain-free injection of tracer and gives surgeons more control.
Dr Peter Beitsch, of Dallas Surgical, who carried out the first Sentimag® procedure in the US, said: “This is a breakthrough in sentinel node detection, allowing surgeons to localise nodes precisely and rapidly without any of the concerns associated with the use of radioactivity. This product has the potential to eliminate radioisotopes in sentinel node biopsy, simplifying the procedure for surgeons and making accurate staging more widely available.”
The system is approved for use in Europe and, since 2012, thousands of cancer patients across 12 European countries have benefited from the new technique. Published results from clinical trials with more than 1,000 breast cancer patients have shown that the Sentimag® and Sienna+® system is safe, and clinically equivalent to the current gold standard for sentinel lymph node detection.
The study aims to provide further clinical evidence that the Sentimag® and Sienna+®system is as safe and effective as the current standard of care with US patients.
Endomag’s products also allow the technique to be rolled out to all hospitals and clinics – even those without access to radioisotope handling facilities, making the procedure more accessible to everyone who needs it.
Dr Mark Gittleman, of Coordinated Health Breast Care Specialists in Pennsylvania, a past president of the American Society of Breast Surgeons, who carried out the second Sentimag® procedure in the US said: “Having used this system in my operating room as part of the clinical trial, I am impressed with its ease of use and that it can bring a new level of accuracy and sensitivity to detecting sentinel lymph nodes. I am excited to be part of this trial which can make a real difference to breast cancer patients across the United States.”
Dr Quentin Harmer, CTO at Endomag, said: “Starting this clinical trial in the USA is a critical step for Endomag in our goal of improving the standard of care for cancer patients around the world. Some of the finest surgeons at cancer centres across the United States are involved in the trial.
We are excited by their enthusiasm about Sentimag® and Sienna+® and the system’s potential to take sentinel node detection to the next level of accuracy and availability.”