Breast Cancer
Conditions
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.
Interventions
DEVICEHoloLens 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.
Sponsors
Florida Breast Cancer Foundation
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Standard of Care, Then 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.
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. | 13 |
| Group 2: HoloLens V2, Then Standard of Care 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.
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. | 14 |
| Total | 27 |
Baseline characteristics
| Characteristic | Group 2: HoloLens V2, Then Standard of Care | Total | Group 1: Standard of Care, Then HoloLens V2 |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 9 Participants | 4 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 18 Participants | 9 Participants |
| Age, Continuous | 55.1 years | 54.9 years | 53.4 years |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 4 Participants | 8 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 3 Participants | 1 Participants |
| Race (NIH/OMB) White | 7 Participants | 15 Participants | 8 Participants |
| Region of Enrollment United States | 14 participants | 27 participants | 13 participants |
| Sex: Female, Male Female | 14 Participants | 27 Participants | 13 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 8 | 0 / 12 | 0 / 8 | 0 / 12 |
| other Total, other adverse events | 4 / 8 | 3 / 12 | 2 / 8 | 4 / 12 |
| serious Total, serious adverse events | 0 / 8 | 0 / 12 | 0 / 8 | 0 / 12 |
Outcome results
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
Time frame: The time frame was from the start of radiation to the 10th fraction of radiation which is approximately two weeks.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Group 1: Standard of Care, Then HoloLens V2 | Number of Computed Tomography (CBCTs) a Participant Receives During Radiation Therapy Treatment as Quantified Via Counting the Number Used During the Setup Process. | First Intervention (Treatments 1-5) | 2 number of measurements |
| Group 1: Standard of Care, Then HoloLens V2 | Number of Computed Tomography (CBCTs) a Participant Receives During Radiation Therapy Treatment as Quantified Via Counting the Number Used During the Setup Process. | Second Intervention (Treatments 6-10) | 3 number of measurements |
| Mixed-reality Guided Patient Setup-Group 2 - HoloLens v2 Phase (Treatments 1-5) | Number of Computed Tomography (CBCTs) a Participant Receives During Radiation Therapy Treatment as Quantified Via Counting the Number Used During the Setup Process. | First Intervention (Treatments 1-5) | 3 number of measurements |
| Mixed-reality Guided Patient Setup-Group 2 - HoloLens v2 Phase (Treatments 1-5) | Number of Computed Tomography (CBCTs) a Participant Receives During Radiation Therapy Treatment as Quantified Via Counting the Number Used During the Setup Process. | Second Intervention (Treatments 6-10) | 3 number of measurements |