UK-based cancer healthcare firm Endomag has completed patient enrolment in its pivotal multi-centre US trial of its Sentimag and Sienna+ system for the treatment of staging breast cancer.
Sienna+ is a magnetic tracer injected into the body. Sentimag is used to track its presence, locating lymph nodes as part of a sentinel lymph node biopsy (SLNB) procedure.
Sienna+ is the first magnetically detected lymphatic mapping agent to be examined in the US under an investigational device exemption (IDE).
A total of 160 patients were enrolled in the SentimagIC trial in ten months at six clinical sites, including major cancer academic institutions such as the University of California San Francisco Cancer Center and MD Anderson Cancer Center, Houston.
The trial compared the Sentimag and Sienna+ magnetic technique with the gold standard radioisotope-based technique for mapping lymph nodes as part of sentinel lymph node biopsy procedure for cancer staging.
The company noted that results from this trial are expected to form the basis for a pre-market approval (PMA) submission to US Food and Drug Administration (FDA).
Sienna+, which is injected 20 minutes before surgery, flows to lymph nodes draining from the primary tumour site that potentially harbour metastatic cancer cells, while the Sentimag handheld probe allows surgeons to accurately locate these sentinel lymph nodes.
Dallas Surgical Group surgeon Dr Peter Beitsch said: "Sentimag and Sienna+ remove the radiation from the operation, as well as the painful injection that often occurs in the nuclear medicine department without anaesthesia.
"It has the potential to make the procedure more convenient for patients and much simpler for hospitals and surgeons."
Both Sentimag and Sienna+ are Class IIa devices, CE approved for marketing and sales in Europe, and TGA approved for Australasia.
In Europe, the system has successfully treated more than 10,000 patients. It is not approved in the US and is available for investigational use only.
Endomag chief technology officer Dr Quentin Harmer said: "Completing enrolment in our pivotal US clinical trial marks an important milestone for Endomag.
"The SentimagIC trial is the first to examine the safety and efficacy of the magnetic sentinel node biopsy technique in the US, and underlines Endomag's commitment to make new cancer staging options available to surgeons and patients worldwide.
"In January, we expect to perform a full analysis of the data and this will support our submission to the FDA later in 2016."
Endomag is focused on improving the global standard cancer care by developing a new, effective clinical platform that uses safe magnetic fields to power diagnostic and therapeutic devices.
Image: Dallas Surgical Group surgeon Dr Peter Beitsch presented a poster about the trial at the San Antonio Breast Cancer Symposium. Photo: courtesy of Endomag.