Recruiting NCT06465966

UFPTI 2403-PR12: Real-Time Volumetric Ionizing Radiation Acoustic Imaging for In-vivo Proton Treatment Monitoring in Pencil-Beam Scanning

No phase Interventional Prostate Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: iRAI.
Who it may be relevant to: Registry conditions: Prostate Cancer. Basic parameters: 18 years — 100 years · Male.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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

Device 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.

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]

Secondary outcome measures (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 [Time frame: Approximately 36 months for trial accrual]

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

A patient who would not be tolerable or will feel nervous about being touched on the skin with a water bag
A patient with a significant medical implant or hardware in the treatment area

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

United States · 1 center

NCT: NCT06465966 · IRB202400573