NCT05178927

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable breast-cancer

Timeline
Completed

Started Aug 2022

Shorter than P25 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 11, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

January 5, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

August 2, 2022

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
11 months until next milestone

Results Posted

Study results publicly available

August 20, 2024

Completed
Last Updated

August 20, 2024

Status Verified

July 1, 2024

Enrollment Period

1.2 years

First QC Date

October 11, 2021

Results QC Date

April 30, 2024

Last Update Submit

July 26, 2024

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • 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

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

Study Arms (2)

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.

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.

Device: HoloLens v2

Interventions

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.

Mixed-reality guided patient setup-Group 2Standard of Care-Group 1

Eligibility Criteria

Age18 Years - 100 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsAs this type of treatment is rare in men, the study will focus on female patients only.
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Male subjects

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Florida Health Proton Therapy Institute

Jacksonville, Florida, 32209, United States

Location

Related Publications (1)

  • 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.

    PMID: 39558366DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Results Point of Contact

Title
Dr. Perry Johnson
Organization
UF Health Proton Therapy Institute
PBJohnson@floridaproton.org
904-588-1253

Study Officials

  • Perry Johnson

    University of Florida

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 11, 2021

First Posted

January 5, 2022

Study Start

August 2, 2022

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

August 20, 2024

Results First Posted

August 20, 2024

Record last verified: 2024-07

Data Sharing

IPD Sharing
Will not share

Locations

US(1)