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NCT06465966
UFPTI 2403-PR12: Real-Time Volumetric Ionizing Radiation Acoustic Imaging for In-vivo Proton Treatment Monitoring in Pencil-Beam Scanning
Conditions: Prostate Cancer
Sex: Male
Ages: 18 Years – 100 Years
Healthy volunteers: No
Phase: NA
Enrollment: 11
Sponsor: University of Florida
Location: Univeristy of Florida Health Proton Therapy Institute Jacksonville Florida
Summary
The purpose of this study is to evaluate the use of ionizing-radiation photo acoustic imaging (iRAI) for proton radiation treatment.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT06465966). StuddyBuddy aggregates publicly available trial information.