Clinical trial · Interventional
UFPTI 2403-PR12: Real-Time Volumetric Ionizing Radiation Acoustic Imaging for In-vivo Proton Treatment Monitoring in Pencil-Beam Scanning
NCT06465966CI-TRIAL-00124207recruitingN/AClinicalTrials.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 evaluate the use of ionizing-radiation photo acoustic imaging (iRAI) for proton radiation treatment.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iRAI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- iRAI data collection
- description
- Radiation therapists will position the participant on the treatment table. After the participant is setup, a water bag will be placed on his abdomen and a 2D transducer is placed on top of the water bag. The 2D transducer is held in place by an articulated arm attached to the treatment table. The water bag serves as a path for the photo acoustic waves created during treatment to be detected by the 2D transducer and captured for data collection.
- interventionNames
- Device: iRAI
Primary outcomes (1)
- measure
- Proton treatment dose overlay between predicted values and iRAI in CT images at the center plane of a tumor to achieve
- timeFrame
- Approximately 36 months for trial accrual
- description
- 95% confidence interval in the gamma passing rate higher than 90% using 5%/5 mm criteria
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Disease: Prostate cancer * Treatment site: * Prostate or prostate and seminal vesicle * No regional lymph node is involved * Patient's body weight: Patient's body weight is less than 350 lbs to consider the total weight limit that the ProteusONE treatment table and the robotic arm can operate * Treatment volume size: maximum size less than 15 x 15 cm in a cross-section and a thickness less than 20 cm to consider 2D transducer matrix size * Provision to sign the consent form and understand the non-invasiveness of iRAI * Patient agreement on tolerance on placing a water bag to acquire iRAI during treatment * Treatment modality: Proton radiation therapy with UFHPTI's ProteusONE gantry using PBS Exclusion Criteria: * A patient who would not be tolerable or will feel nervous due to the sensation and coolness of the ultrasound gel appliedt to skin * A patient with a significant medical implant or hardware in the treatment area * A patient may feel uncomfortable with the modular transducer arrays contacting the skin during treatment. Each transducer array contacts a 15 cm × 15 cm area of skin, and depending on the patient's abdominal size, a minimum of two and a maximum of three such areas may be in contact. This produces a sensation of light pressure on the abdomen - comparable to a light hold on the index finger - lasting for a total of 4 minutes.
References
Publications (0)
Data not yet available
No reference posted for this study.