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

A study testing HoloLens v2 in people with Breast Cancer, run by University of Florida at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 18 to 100 years, women only
Conditions the study is for: Breast Cancer
What is being tested?: HoloLens v2
Type of treatment: Medical device
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 27 participants
Where: 1 siteUnited States
Study dates: 2 Aug 2022to 30 Sep 2023
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 100 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

Male subjects

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Florida Health Proton Therapy Institute
Jacksonville, Florida, 32209

Other trials in United States

About this study

Conditions: Breast Cancer
Being tested: HoloLens v2
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

HoloLens v2Device
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.

Study groups in NCT05178927
Study group	Role	What they receive
Standard of Care-Group 1	Sham comparator	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. Receives: Device: HoloLens v2
Mixed-reality guided patient setup-Group 2	Experimental	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. Receives: Device: HoloLens v2

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: The time frame was from the start of radiation to the 10th fraction of radiation which is approximately two weeks.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Aug 202230 Sep 2023

First posted5 Jan 2022
Study start2 Aug 2022
Primary completion30 Sep 2023
Study completion30 Sep 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by University of FloridaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 27 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05178927
Sponsor's protocol ID: IRB202101449
Status last verified: Jul 2024
First submitted: 11 Oct 2021
Last updated: 20 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Johnson PB, Bradley J, Lampotang S, Jackson A, Lizdas D, Johnson W, Brooks E, Vega RBM, Mendenhall N. First-in-human trial using mixed-reality visualization for patient setup during breast or chest wall radiotherapy. Radiat Oncol. 2024 Nov 18;19(1):163. doi: 10.1186/s13014-024-02552-0.
PubMed 39558366

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: UFPTI 2105-BR05: Improving Breast Radiotherapy Setup and Delivery Using Mixed-Reality Visualization
ClinicalTrials.gov ID: NCT05178927
Acronym / sponsor ID: IRB202101449
Conditions: Breast Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 27 participants (actual)
Lead sponsor: University of FloridaUniversity, hospital or other
Collaborators: Florida Breast Cancer Foundation
Study start: 2 Aug 2022 (actual)
Primary completion: 30 Sep 2023 (actual)
Study completion: 30 Sep 2023 (actual)
First posted: 5 Jan 2022 (actual)
Results: Posted 20 Aug 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Standard of Care-Group 1	Sham comparator	Device: HoloLens v2During 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	Experimental	Device: HoloLens v2During 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.

Who may qualify

Ages: 18 to 100 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

Male subjects

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
HoloLens v2The 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.	Device	Mixed-reality guided patient setup-Group 2, Standard of Care-Group 1

Primary outcome

Number of Computed Tomography (CBCTs) 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.
Counting the number of computed tomography a participant receives during radiation therapy treatment as quantified via counting the number used during the setup process

Results and safety

Results posted to the registry on 20 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group 1: Standard of Care, Then HoloLens V2	13	8
Group 2: HoloLens V2, Then Standard of Care	14	12

Primary outcome: Number of Computed Tomography (CBCTs) 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.. Median (Full Range). Unit: number of measurements

Measure	Group 1: Standard of Care, Then HoloLens V2 n = 8	Mixed-reality Guided Patient Setup-Group 2 - HoloLens v2 Phase (Treatments 1-5) n = 12
First Intervention (Treatments 1-5)	2 (1 to 6)	3 (1 to 5)
Second Intervention (Treatments 6-10)	3 (1 to 7)	3 (1 to 5)

Adverse events

Time frame: Through completion of 7 week radiation therapy course.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group 1a: Standard of Care (1st Phase)	0 of 8 (0%)	4 of 8 (50%)	0 of 8
Group 2a: HoloLens V2 (1st Phase)	0 of 12 (0%)	3 of 12 (25%)	0 of 12
Group 1b: HoloLens V2 (2nd Phase)	0 of 8 (0%)	2 of 8 (25%)	0 of 8
Group 2b: Standard of Care (2nd Phase)	0 of 12 (0%)	4 of 12 (33.3%)	0 of 12

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39558366Johnson PB, Bradley J, Lampotang S, Jackson A, Lizdas D, Johnson W, Brooks E, Vega RBM, Mendenhall N. First-in-human trial using mixed-reality visualization for patient setup during breast or chest wall radiotherapy. Radiat Oncol. 2024 Nov 18;19(1):163. doi: 10.1186/s13014-024-02552-0.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Perry Johnson principal investigator

University of Florida

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing HoloLens v2 in people with Breast Cancer, run by University of Florida at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Computed Tomography (CBCTs) 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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05178927, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024; AzTrials last refreshed its copy on 1 Nov 2026.