UFPTI 2403-PR12: Real-Time Volumetric Ionizing Radiation Acoustic Imaging for In-vivo Proton Treatment Monitoring in Pencil-Beam Scanning
Recruiting · NCT06465966 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Florida
View the official record on ClinicalTrials.gov →Interventions studied
iRAI
What this trial is about
The purpose of this study is to evaluate the use of ionizing-radiation photo acoustic imaging (iRAI) for proton radiation treatment.
Who can take part
Age range
18 Years to 100 Years
Sex
Male
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed across 1 US state.
- Univeristy of Florida Health Proton Therapy Institute - Jacksonville, Florida, United States