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| Name | Class |
|---|---|
| Florida Breast Cancer Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HoloLens v2 | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
As this type of treatment is rare in men, the study will focus on female patients only.
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| Name | Affiliation | Role |
|---|---|---|
| Perry Johnson | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida Health Proton Therapy Institute | Jacksonville | Florida | 32209 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39558366 | Derived | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (Treatments 1-5) |
| |||||||||||||
| Second Intervention (Treatments 6-10) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Median | Full Range | number of measurements | The time frame was from the start of radiation to the 10th fraction of radiation which is approximately two weeks. |
|
Through completion of 7 week radiation therapy course.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1a: Standard of Care (1st Phase) | 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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Breast atrophy | Reproductive system and breast disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Perry Johnson | UF Health Proton Therapy Institute | 904-588-1253 | PBJohnson@floridaproton.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 2, 2023 | Apr 1, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| NOT COMPLETED |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| OG001 | Mixed-reality Guided Patient Setup-Group 2 - HoloLens v2 Phase (Treatments 1-5) | 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. |
|
|
| 0 |
| 8 |
| 0 |
| 8 |
| 4 |
| 8 |
| EG001 | Group 2a: HoloLens V2 (1st Phase) | 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. | 0 | 12 | 0 | 12 | 3 | 12 |
| EG002 | Group 1b: HoloLens V2 (2nd Phase) | 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. | 0 | 8 | 0 | 8 | 2 | 8 |
| EG003 | Group 2b: Standard of Care (2nd Phase) | 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. | 0 | 12 | 0 | 12 | 4 | 12 |
| Breast pain | Reproductive system and breast disorders | Systematic Assessment |
|
| Radiation dermatitis | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Esophagitis | Gastrointestinal disorders | Systematic Assessment |
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| Fatigue | General disorders | Systematic Assessment |
|
| Seroma | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin hyperpigmentation | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
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| D017437 |
| Skin and Connective Tissue Diseases |