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

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: HoloLens v2

• Registration Number: NCT05178927
• Lead Sponsor: University of Florida

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-10-11
• Study First Submitted QC: 2022-01-04
• Study First Posted: 2022-01-05
• Study Start: 2022-08-02
• Primary Completion: 2023-09-30
• Study Completion: 2023-09-30
• Results First Submitted: 2024-04-30
• Status Verified: 2024-07
• Results First Submitted QC: 2024-07-26
• Last Update Submitted: 2024-07-26
• Results First Posted: 2024-08-20
• Last Update Posted: 2024-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 27

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Standard of Care-Group 1	HoloLens v2	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.
Mixed-reality guided patient setup-Group 2	HoloLens v2	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.

Primary Outcome Measures

Name	Time	Method
Number of Computed Tomography (CBCTs) a Participant Receives During Radiation Therapy Treatment as Quantified Via Counting the Number Used During the Setup Process.	The time frame was from the start of radiation to the 10th fraction of radiation which is approximately two weeks.	Counting the number of computed tomography a participant receives during radiation therapy treatment as quantified via counting the number used during the setup process

Trial Locations

Locations (1)

University of Florida Health Proton Therapy Institute; 🇺🇸 Jacksonville, Florida, United States