Prostate CancerNCT06465966
UFPTI 2403-PR12: Real-Time Volumetric Ionizing Radiation Acoustic Imaging for In-vivo Proton Treatment Monitoring in Pencil-Beam Scanning
A study testing iRAI in people with Prostate Cancer, run by University of Florida at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the use of ionizing-radiation photo acoustic imaging (iRAI) for proton radiation treatment. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- iRAI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Sep 2024to 1 Oct 2027
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Univeristy of Florida Health Proton Therapy Institute
Jacksonville, Florida, 32206
About this study
The purpose of this study is to evaluate the use of ionizing-radiation photo acoustic imaging (iRAI) for proton radiation treatment.
- Conditions
- Prostate Cancer
- Being tested
- iRAI
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iRAIDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: iRAI |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Approximately 36 months for trial accrual
Secondary outcomes (1)
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
Measured: Approximately 36 months for trial accrual
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2024
- Study start23 Sep 2024
- Primary completion1 Sep 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06465966
- Sponsor's protocol ID
- IRB202400573
- Status last verified
- Oct 2026
- First submitted
- 14 Jun 2024
- Last updated
- 13 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes