Researchers at the University of Maryland School of Medicine will start a clinical trial to test the efficacy of GammaPod image-guided radiation therapy system to treat early-stage breast cancer.
Developed at the university, the GammaPod system uses precisely focused beams of radiation from 36 rotating sources in combination with a two-layer, vacuum-assisted cup.
This immobilizes the breast to attain accuracy within 2mm.
Xcision Medical Systems has produced the GammaPod system, based on a patent from the University of Maryland.
Xcision Medical Systems CEO and University of Maryland School of Medicine radiation oncology clinical professor Dr Cedric Yu said: "With standard therapy, patients with early-stage breast cancer have surgery to remove the tumor, followed by five to seven weeks of radiation treatments to destroy any residual cancer cells."
The trial will enroll 17 patients to assess clinical feasibility and safety of the system.
US Food and Drug Administration’s (FDA) approval will be sought based on the data.
The study is expected to begin by early November, once the university completes approval process with the Maryland Department of the Environment.
Researchers will carry out the trial at the University of Maryland Medical Center.
University of Maryland School of Medicine radiation oncology professor and study principal investigator Dr Steven Feigenberg said:"GammaPod is the first system designed to treat early breast cancer with stereotactic precision which will allow for high-dose radiation therapy, otherwise known as stereotactic body radiotherapy, or SBRT."
Image: Xcision Medical Systems CEO Dr Cedric Yu. Photo: courtesy of University of Maryland School of Medicine.