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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05178927
• Other study ID #: IRB202101449
• Status: Completed
• Phase: N/A
• Start date: August 2, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2023
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: September 30, 2023
• Est. primary completion date: September 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• 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.

Locations

Country	Name	City	State
United States	University of Florida Health Proton Therapy Institute	Jacksonville	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of Florida	Florida Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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