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Recruiting

NCT Number: NCT06465966

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

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

Recruiting

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year–100 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Univeristy of Florida Health Proton Therapy Institute

Jacksonville, Florida, 32206, United States

Location status: Recruiting

Location contact

Jiyeon Park

CONTACT

[email protected]

904-588-1800

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

iRAI

Device

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 outcomes

  1. 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

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

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

    Time frame: Approximately 36 months for trial accrual

    Standard error of less than 5% between the passing rates when using a 5 mm distance-to-agreement

Study contacts

Contact information is provided by the study sponsor or research team.

Jiyeon Park

CONTACT

[email protected]

904-588-1800

Sponsors and collaborators

Lead sponsor

University of Florida

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jun 20, 2024
Registry last updated
Jan 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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