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

University of Florida

Status: Completed

Conditions: Breast Cancer

Treatments: Device: HoloLens v2

Study type: Interventional

Funder types: Other

Identifiers

NCT05178927

IRB202101449

Details and patient eligibility

About

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.

Enrollment: 27 patients

Sex: Female

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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27 participants in 2 patient groups

Standard of Care-Group 1

Sham Comparator group

Description:

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.

Treatment:

Device: HoloLens v2

Mixed-reality guided patient setup-Group 2

Experimental group

Description:

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.

Treatment:

Device: HoloLens v2