Recruiting

Proton Treatment Monitoring

Sponsor:

University of Florida

Code:

NCT06465966

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

iRAI

Study Details

Brief summary:

The purpose of this study is to evaluate the use of ionizing-radiation photo acoustic imaging (iRAI) for proton radiation treatment.

Conditions

Prostate Cancer

Study ID

NCT06465966

Start date

Sep 23, 2024

Status verified date

Jan, 2026

Completion date

Oct 1, 2027

Anticipated

Primary completion date

Sep 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: iRAI data collection

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.

Interventions

iRAI

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.

Primary outcome measure

  • Proton treatment dose overlay between predicted values and iRAI in CT images at the center plane of a tumor to achieve [ Time Frame: Approximately 36 months for trial accrual ]

Central Contacts and Locations

Central contacts

Hardev Grewal

904-588-1800hgrewal@floridaproton.org

Locations

Univeristy of Florida Health Proton Therapy Institute

Recruiting

Jacksonville, Florida, United States, 32206

Contacts

Jiyeon Park

904-588-1800jpark@floridaproton.org

More Information

Sponsor

University of Florida

Last update posted

Aug 27, 2026

Last verified

Jan, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2026-08-27.