UFPTI 2105-BR05: Improving Breast Radiotherapy Setup and Delivery Using Mixed-Reality Visualization

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-02

Study Completion Date

2023-09-30

Brief Summary

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The purpose of this study is to compare the accuracy, set-up time, and amount of image-guided radiotherapy (IGRT - a system that helps line up the radiation beam with the tumor for treatment) needed when mixed-reality guided radiotherapy is used for treatment set-up.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Standard of Care-Group 1

During treatments 1-5, radiation therapists will position the participant for treatment using the standard of care method.

During treatments 6-10, radiation therapists will use the hologram the investigators created to initially position the participant for treatment. The participant's final position will be obtained using a standard of care method.

Group Type SHAM_COMPARATOR

HoloLens v2

Intervention Type DEVICE

The HoloLens v2 will be used to access the participant's hologram \& set the participant up for treatment. Standard of care methods will be utilized to confirm treatment set-up.

Mixed-reality guided patient setup-Group 2

During treatments 1-5, radiation therapists will use the hologram the investigators created to initially position the participant for treatment. The participant's final position will be obtained using a standard of care method.

During treatments 6-10, radiation therapists will position the participant for treatment using the standard of care method.

Group Type EXPERIMENTAL

HoloLens v2

Intervention Type DEVICE

The HoloLens v2 will be used to access the participant's hologram \& set the participant up for treatment. Standard of care methods will be utilized to confirm treatment set-up.

Interventions

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HoloLens v2

The HoloLens v2 will be used to access the participant's hologram \& set the participant up for treatment. Standard of care methods will be utilized to confirm treatment set-up.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Targets adult patients who are planning to undergo photon or proton radiation therapy at UFHPTI for treatment of the breast or chest wall. As this type of treatment is rare in men, the study will focus on female patients only.