Endomag completes patient enrolment of U.S. pivotal trial for Sentimag® and Sienna+®
Endomag has completed enrolment in the pivotal multi-centre U.S. trial of its Sentimag® and Sienna+® system for staging breast cancer.
The six clinical sites enrolled 160 subjects in 10 months, completing ahead of schedule, and included some of the world’s leading cancer academic institutions, among them the University of California San Francisco Cancer Center and MD Anderson Cancer Center, Houston.
The SentimagIC 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.
Sienna+® is the first magnetically detected lymphatic mapping agent to be trialled in the US under an Investigational Device Exemption (IDE), and the results of the trial are expected to form the basis for a Pre-Market Approval (PMA) submission to the FDA.
Injected 20 minutes before surgery, Sienna+® flows to the lymph nodes draining from the primary tumour site that potentially harbour metastatic cancer cells. The Sentimag®handheld probe allows surgeons to locate these sentinel lymph nodes with great accuracy.
"Completing enrolment in our pivotal U.S. clinical trial marks an important milestone for Endomag."Dr Quentin Harmer CTO, Endomag
Dr Peter Beitsch, surgeon at Dallas Surgical Group, who will be presenting a poster about the trial at the San Antonio Breast Cancer Symposium this week (December 8-12), 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.”
The Sentimag® and Sienna+® are Class IIa devices, CE-approved for marketing and sales in Europe, and TGA-approved for Australasia. The system has successfully treated more than 10,000 patients across Europe. Sentimag® and Sienna+® are not approved in the U.S. and are available for investigational use only.
Dr Quentin Harmer, CTO at Endomag, said:
“Completing enrolment in our pivotal U.S. 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 United States, 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.”