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

Study Overview
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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.

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

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: HoloLens v2


Participation Criteria
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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. Exclusion Criteria: Male subjects

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sham Comparator: Standard of Care-Group 1<br>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. | Device: HoloLens v2<br>* 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.<br>|
| Experimental: Mixed-reality guided patient setup-Group 2<br>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. | Device: HoloLens v2<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of computed tomography (CBCTs) a participant receives during radiation therapy treatment as quantified via counting the number used during the setup process. | Counting the number of computed tomography a participant receives during radiation therapy treatment as quantified via counting the number used during the setup process | Approximately 12 months for trial accrual |