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Proton Treatment Monitoring with iRAI for Prostate Cancer

This study is testing a new imaging method called ionizing-radiation photo acoustic imaging (iRAI) during proton radiation treatment for prostate cancer. iRAI uses sound waves to create images from inside your body, and researchers will use it to see how well the radiation is delivered and how much dose you receive. The goal is to compare the radiation dose shown by iRAI with what was predicted. You may be able to join if you are a man between 18 and 100 years old with prostate cancer that has not spread to regional lymph nodes, and meet certain weight and tumor size requirements. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 30 participants. The study is evaluating a device called iRAI.
What's involved
Researchers will collect iRAI images during your radiation treatments. The primary endpoint will be measured at approximately 36 months for trial accrual.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at approximately 36 months for trial accrual, which suggests a follow-up period.

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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

Recruiting
NAAges 18+Interventional
University of Florida
~30 participants
Updated 2026-08-27 on ClinicalTrials.gov
What's tested:iRAI

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proton treatment dose overlay between predicted values and iRAI in CT images at the center plane of a tumor to achieve
Measured over Approximately 36 months for trial accrual

Conditions

Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Florida1

Who to contact

Hardev Grewal
[email protected]
904-588-1800
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • Proton treatment dose overlay between predicted values and iRAI in CT images at the center plane of a tumor to achieveApproximately 36 months for trial accrual

    95% confidence interval in the gamma passing rate higher than 90% using 5%/5 mm criteria