The only way to remove microscopic cancer tumors remaining from surgery, cold atmospheric plasma technology, has been approved by the U.S. Food and Drug Administration (FDA) for first-ever use in a clinical trial.
When solid tumors are removed via chemotherapy, radiation, surgery or all of the above, microscopic cancer tumors can sometimes remain. When these tumors aren’t fully removed, they can cause the cancer to come back.
Approximately 20% to 40% of women undergoing partial mastectomy in the U.S. each year return to surgery due to marginal tumors that the surgeon couldn’t see the first time around.
A multi-institute team, including Purdue University aerospace engineer Alexey Shashurin, developed pen-like electrosurgical scalpel that sprays a blue jet of cold plasma at any remaining cancerous tissue or cells for 2-7 minutes. The device targets only tumors, leaving the surrounding tissue unharmed as demonstrated in vitro, in vivo, and in FDA approved compassionate use cases prior to the clinical trial, reports Purdue University in a news release.
The investigational technology, approved by the FDA for the phase I clinical trial, will include 20 patients.
The Research Team
The sponsors and investigators include the Purdue University aerospace engineer as well as U.S. Medical Innovations LLC (USMI) and the Jerome Canady Research Institute for Advanced Biological and Technological Sciences (JCRI/ABTS). They plan on enrolling patients in September 2019.
The Investigational Product
USMI developed and patented the first high-frequency electrosurgical generator with cold plasma for the selective treatment of cancer in 2014. The FDA approved the technology for the phase I clinical trial. The product was developed by the Jerome Canady Research, JCRI, USMI and a research professor in the School of Engineering and Applied Sciences at the George Washington University; an engineering team led by Taisen Zhuang, vice president USMI developed and patented the first high-frequency electrosurgical generator with cold plasma for the selective treatment of cancer in 2014.
Clinical Research Sites
Rush University Chicago will be one of the sites for this device; Shashurin’s lab at Purdue will continue to collaborate with USMI on further development of the technology.