混合现实可视化技术在乳腺癌或胸壁放射治疗中患者摆位的首次人体临床试验。

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

机构信息

University of Florida Health Proton Therapy Institute, Jacksonville, FL, USA.

University of Florida College of Medicine, Gainesville, FL, USA.

出版信息

Radiat Oncol. 2024 Nov 18;19(1):163. doi: 10.1186/s13014-024-02552-0.

DOI:10.1186/s13014-024-02552-0

PMID:39558366

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11574990/

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.

摘要

背景

本研究旨在评估混合现实（MixR）可视化在乳腺癌和胸壁放射治疗（RT）患者摆位中的可行性，通过首次人体临床试验比较 MixR 与三点对齐的方法。

方法

对接受质子（n=10）或光子（n=8）放疗的乳腺癌或胸壁患者，在其 RT 治疗过程中纳入 MixR 进行研究，该研究获得了机构审查委员会的批准。对于每位患者，使用 MixR 进行五份分次治疗，并与另五份分次治疗使用三点对齐进行比较。在使用 MixR 的分次治疗中，至少有一位佩戴 HoloLens 2 设备的治疗师对患者进行对齐，该治疗师能够通过同时直接查看患者和源自其模拟 CT 扫描的患者表面的全息图来指导对齐过程。对于光子治疗，使用锥形束 CT（CBCT）定量评估对准精度，对于质子治疗，使用 CBCT 加千伏/千伏成像评估对准精度。在整个摆位过程中跟踪注册时间以及最终对准所使用的图像引导（IGRT）量。

结果

在质子队列中，使用三点对齐的平均 3D 移位为 0.96cm，使用 MixR 的平均 3D 移位为 1.18cm。等效性检验表明，两种技术的注册精度差异小于 0.5cm。在光子队列中，使用三点对齐的平均 3D 移位为 1.18cm，使用 MixR 的平均 3D 移位为 1.00cm。等效性检验表明，两种技术的注册精度差异小于 0.3cm。在注册时间和 IGRT 使用量方面观察到较小的差异。