Researchers from the Department of Radiation Oncology at the University of Maryland School of Medicine (UM SOM) will start a clinical trial to evaluate the efficacy of GammaPod image-guided radiation therapy system for the treatment of early stage breast cancer.
Developed at UM SOM, the GammaPod system uses thousands of precisely focused beams of radiation from 36 rotating sources in combination with a two-layer, vacuum-assisted cup that immobilises the breast to attain accuracy within 2mm.
Xcision Medical Systems produced the GammaPod system, based on a patent from the University of Maryland.
Xcision Medical Systems CEO Dr Cedric Yu said: "With standard therapy, patients with early stage breast cancer have surgery to remove the tumour, followed by five to seven weeks of radiation treatments to destroy any residual cancer cells.
"We believe that GammaPod has the potential to significantly shorten the treatment time to a few sessions over the course of a week, and in the future, potentially eliminate the need for surgery in select patients."
The trial is designed to enrol 17 patients to evaluate clinical feasibility and safety of the system. US Food and Drug Administration’s (FDA) approval will be sought based on the trial data.
Results of the initial study will be submitted to the FDA, which will decide whether to grant the 510(k) application to market the device.
If the application is approved, additional clinical trials to further test the technology will be conducted.
University of Maryland School of Medicine radiation oncology professor Dr Steven Feigenberg leads a clinical consortium of four other medical centres in the US and Canada, where GammaPod will be available over the next year. Researchers at those sites are working together to develop clinical protocols.
The trial is expected to begin by early November, once the university completes the approval process with the Maryland Department of the Environment.
Researchers will carry out the trial at the University of Maryland Medical Center.
Feigenberg said :"GammaPod is the first system designed to treat early breast cancer with stereotactic precisio,n which will allow for high-dose radiation therapy, otherwise known as stereotactic body radiotherapy, or SBRT."