Clinical trial · Interventional
UFPTI 2105-BR05: Improving Breast Radiotherapy Setup and Delivery Using Mixed-Reality Visualization
NCT05178927CI-TRIAL-00079962completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| HoloLens v2 | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- SHAM_COMPARATOR
- label
- Standard of Care-Group 1
- description
- 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.
- interventionNames
- Device: HoloLens v2
- type
- EXPERIMENTAL
- label
- Mixed-reality guided patient setup-Group 2
- description
- 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.
- interventionNames
- Device: HoloLens v2
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDJohnson 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 39558366