A prospective trial of single-fraction radiation to the tumor bed with a novel breast-specific stereotactic radiotherapy device: The GammaPod

The GammaPod is a novel breast-specific stereotactic radiosurgery device. This study was undertaken to show safety and feasibility as part of the Investigational Device Exemption clearance process. A boost was delivered in a single fraction of 8 Gy prior to whole-breast radiation therapy. The device was found to be safe and feasible for clinical use with acceptable acute toxicities. The results from this study led to FDA clearance of the device.