RecruitingInterventional

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

NCT ID: NCT06465966Sponsor: University of FloridaLast updated: 2026-01-15

Summary

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

Arms & interventions

DeviceiRAI
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.

Outcome measures

Primary

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
Time frame: Approximately 36 months for trial accrual

Secondary

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

Eligibility criteria

Sex: MaleAge: 18 Years to 100 YearsHealthy volunteers: No

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 about being touched on the skin with a water bag * A patient with a significant medical implant or hardware in the treatment area

Study locations (1)

Univeristy of Florida Health Proton Therapy Institute

Jacksonville, Florida, 32206

Recruiting

Jiyeon Park · Contact

904-588-1800 jpark@floridaproton.org