First-in-human trial using mixed-reality visualization for patient setup during breast or chest wall radiotherapy

Abstract

Abstract Background The purpose of this study is to assess the feasibility of mixed-reality (MixR) visualization for patient setup in breast and chest wall radiotherapy (RT) by performing a first-in-human clinical trial comparing MixR with a 3-point alignment. Methods IRB approval was granted for a study incorporating MixR during the setup process for patients undergoing proton (n = 10) or photon (n = 8) RT to the breast or chest wall. For each patient, MixR was utilized for five fractions and compared against another five fractions using 3-point alignment. During fractions with MixR, the patient was aligned by at least one therapist wearing a HoloLens 2 device who was able to guide the process by simultaneously and directly viewing the patient and a hologram of the patient’s surface derived from their simulation CT scan. Alignment accuracy was quantified with cone-beam CT (CBCT) for photon treatments and CBCT plus kV/kV imaging for proton treatments. Registration time was tracked throughout the setup process as well as the amount of image guidance (IGRT) utilized for final alignment. Results In the proton cohort, the mean 3D shift was 0.96 cm using 3-point alignment and 1.18 cm using MixR. An equivalence test indicated that the difference in registration accuracy between the two techniques was less than 0.5 cm. In the photon cohort, the mean 3D shift was 1.18 cm using 3-point alignment and 1.00 cm using MixR. An equivalence test indicated that the difference in registration accuracy was less than 0.3 cm. Minor differences were seen in registration time and the amount of IGRT utilization. Conclusions MixR for patient setup for breast cancer RT is possible at the level of accuracy and efficiency provided by a 3-point alignment. Further developments in marker tracking, feedback, and a better understanding of the perceptual challenges of MixR are needed to achieve a similar level of accuracy as provided by modern surface-guided radiotherapy (SGRT) systems. Trial registration ClinicalTrials.gov, UFHPTI 2015-BR05: Improving Breast Radiotherapy Setup and Delivery Using Mixed-Reality Visualization, NCT05178927.