Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to evaluate the use of ionizing-radiation photo acoustic imaging (iRAI) for proton radiation treatment.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| iRAI data collection | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| iRAI | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Proton treatment dose overlay between predicted values and iRAI in CT images at the center plane of a tumor to achieve | 95% confidence interval in the gamma passing rate higher than 90% using 5%/5 mm criteria | Approximately 36 months for trial accrual |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Standard error of less than 5% between the passing rates when using a 5 mm distance-to-agreement | Approximately 36 months for trial accrual |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jiyeon Park | Contact | 904-588-1800 | jpark@floridaproton.org |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Univeristy of Florida Health Proton Therapy Institute | Recruiting | Jacksonville | Florida | 32206 | United States |
Not provided
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |