Prostate Cancer
Conditions
Brief summary
The purpose of this study is to evaluate the use of ionizing-radiation photo acoustic imaging (iRAI) for proton radiation treatment.
Interventions
DEVICEiRAI
Ionizing-radiation photo acoustic imaging (iRAI) is a method of collecting images from inside the body using acoustic (sound) waves. Researchers will collect iRAI during a participant's radiation treatments. Researchers will use this imaging to examine the delivery and dose of the radiation to the participant's prostate. Researchers will also compare the delivery and dose calculated from iRAI to the expected doses that were calculated from CT images which are done as standard of care.
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proton treatment dose overlay between predicted values and iRAI in CT images at the center plane of a tumor to achieve | Approximately 36 months for trial accrual | 95% confidence interval in the gamma passing rate higher than 90% using 5%/5 mm criteria |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reliability of range discrepancies between predicted values and iRAI during 3-day treatments at the proximal, center, and distal plane of a tumor to achieve | Approximately 36 months for trial accrual | Standard error of less than 5% between the passing rates when using a 5 mm distance-to-agreement |
Countries
United States
Contacts
CONTACTHardev Grewal
Outcome results
None listed