X-ray Target Shielding and Leakage Radiation Inside the Treatment Capsule of the Zap-X

The ZAP-X represents the first-of-its-kind "self-shielded" therapeutic radiation device, which by novelty, challenges regulators to accommodate it within the existing regulatory framework for radiation protection. To facilitate informed regulatory interpretation, X-ray radiation leakage from the ZAP-X was measured inside the shielded treatment capsule at the level of the patient and X-ray target plane. Measurements were performed on a clinically commissioned system calibrated for reference conditions to deliver 1cGy/MU. Radiation was measured with a FLUKE 451 survey meter and a RadCal ionization chamber as both exposure and dose and presented as a percentage of the system reference dose. Measurements were taken at thirteen locations, eight in the patient plane and five in the X-ray target plane. The results showed a maximum X-ray leakage of 0.000986% in the patient plane and 0.000907% in the target plane. These results are 30 - 100 times lower than existing recommendations as referenced by IEC guidelines standard 60601-2-1 (2020) for radiotherapy linear accelerators (LINACs). Although most conventional LINACs apply a safety factor of 2-5 to the design of collimator shielding and patient dose sparing, the ZAP-X delivers less than 10% of the patient whole body dose compared to this standard, originating from the X-ray target. Even though the ZAP-X intensity modulated radiation therapy (IMRT) factor is significantly higher than conventional Linacs, the absolute dose originating from leakage radiation remains lower by 25. The amount of unintended dose received by the patient's body distant from the isocenter is of interest from the perspective of both clinical and radiation safety. As this whole-body dose is decreased, the resulting treatment-related cancer incidence and mortality rates are decreased accordingly.