Trial Outcomes & Findings for UFPTI 2105-BR05: Improving Breast Radiotherapy Setup and Delivery Using Mixed-Reality Visualization (NCT NCT05178927)
NCT ID: NCT05178927
Last Updated: 2024-08-20
Results Overview
Counting the number of computed tomography a participant receives during radiation therapy treatment as quantified via counting the number used during the setup process
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
The time frame was from the start of radiation to the 10th fraction of radiation which is approximately two weeks.
Results posted on
2024-08-20
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
First Intervention (Treatments 1-5)
STARTED
|
13
|
14
|
|
First Intervention (Treatments 1-5)
COMPLETED
|
8
|
12
|
|
First Intervention (Treatments 1-5)
NOT COMPLETED
|
5
|
2
|
|
Second Intervention (Treatments 6-10)
STARTED
|
8
|
12
|
|
Second Intervention (Treatments 6-10)
COMPLETED
|
8
|
12
|
|
Second Intervention (Treatments 6-10)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
UFPTI 2105-BR05: Improving Breast Radiotherapy Setup and Delivery Using Mixed-Reality Visualization
Baseline characteristics by cohort
| Measure |
Group 1: Standard of Care, Then HoloLens V2
n=13 Participants
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.
|
Group 2: HoloLens V2, Then Standard of Care
n=14 Participants
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.
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Age, Continuous
|
53.4 years
n=5 Participants
|
55.1 years
n=7 Participants
|
54.9 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
14 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
Group 1: Standard of Care, Then HoloLens V2
n=8 Participants
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.
|
Mixed-reality Guided Patient Setup-Group 2 - HoloLens v2 Phase (Treatments 1-5)
n=12 Participants
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.
|
|---|---|---|
|
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
Interval 1.0 to 7.0
|
3 number of measurements
Interval 1.0 to 5.0
|
|
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
Interval 1.0 to 6.0
|
3 number of measurements
Interval 1.0 to 5.0
|
Adverse Events
Group 1a: Standard of Care (1st Phase)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 2a: HoloLens V2 (1st Phase)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 1b: HoloLens V2 (2nd Phase)
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2b: Standard of Care (2nd Phase)
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1a: Standard of Care (1st Phase)
n=8 participants at risk
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.
|
Group 2a: HoloLens V2 (1st Phase)
n=12 participants at risk
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.
|
Group 1b: HoloLens V2 (2nd Phase)
n=8 participants at risk
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.
|
Group 2b: Standard of Care (2nd Phase)
n=12 participants at risk
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.
|
|---|---|---|---|---|
|
Reproductive system and breast disorders
Breast atrophy
|
0.00%
0/8 • Through completion of 7 week radiation therapy course.
|
0.00%
0/12 • Through completion of 7 week radiation therapy course.
|
12.5%
1/8 • Number of events 1 • Through completion of 7 week radiation therapy course.
|
0.00%
0/12 • Through completion of 7 week radiation therapy course.
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/8 • Through completion of 7 week radiation therapy course.
|
0.00%
0/12 • Through completion of 7 week radiation therapy course.
|
25.0%
2/8 • Number of events 2 • Through completion of 7 week radiation therapy course.
|
0.00%
0/12 • Through completion of 7 week radiation therapy course.
|
|
Skin and subcutaneous tissue disorders
Radiation dermatitis
|
25.0%
2/8 • Number of events 2 • Through completion of 7 week radiation therapy course.
|
0.00%
0/12 • Through completion of 7 week radiation therapy course.
|
12.5%
1/8 • Number of events 1 • Through completion of 7 week radiation therapy course.
|
16.7%
2/12 • Number of events 2 • Through completion of 7 week radiation therapy course.
|
|
Gastrointestinal disorders
Esophagitis
|
12.5%
1/8 • Number of events 1 • Through completion of 7 week radiation therapy course.
|
0.00%
0/12 • Through completion of 7 week radiation therapy course.
|
12.5%
1/8 • Number of events 1 • Through completion of 7 week radiation therapy course.
|
8.3%
1/12 • Number of events 1 • Through completion of 7 week radiation therapy course.
|
|
General disorders
Fatigue
|
37.5%
3/8 • Number of events 3 • Through completion of 7 week radiation therapy course.
|
16.7%
2/12 • Number of events 2 • Through completion of 7 week radiation therapy course.
|
25.0%
2/8 • Number of events 2 • Through completion of 7 week radiation therapy course.
|
16.7%
2/12 • Number of events 2 • Through completion of 7 week radiation therapy course.
|
|
Skin and subcutaneous tissue disorders
Seroma
|
12.5%
1/8 • Number of events 1 • Through completion of 7 week radiation therapy course.
|
25.0%
3/12 • Number of events 3 • Through completion of 7 week radiation therapy course.
|
0.00%
0/8 • Through completion of 7 week radiation therapy course.
|
8.3%
1/12 • Number of events 1 • Through completion of 7 week radiation therapy course.
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/8 • Through completion of 7 week radiation therapy course.
|
0.00%
0/12 • Through completion of 7 week radiation therapy course.
|
0.00%
0/8 • Through completion of 7 week radiation therapy course.
|
8.3%
1/12 • Number of events 1 • Through completion of 7 week radiation therapy course.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place