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

Not Applicable

Recruiting

• Conditions: Prostate Cancer

• Registration Number: NCT06465966
• Lead Sponsor: University of Florida

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-06-14
• Study First Submitted QC: 2024-06-18
• Study First Posted: 2024-06-20
• Study Start: 2024-09-23
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-13
• Last Update Posted: 2024-11-15
• Primary Completion: 2026-09-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Proton treatment dose overlay between predicted values and iRAI in CT images at the center plane of a tumor to achieve	Approximately 24 months for trial accrual	95% confidence interval in the gamma passing rate higher than 90% using 5%/5 mm criteria

Secondary Outcome Measures

Name	Time	Method
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	Approximately 24 months for trial accrual	Standard error of less than 5% between the passing rates when using a 5 mm distance-to-agreement

Trial Locations

Locations (1)

Univeristy of Florida Health Proton Therapy Institute; 🇺🇸 Jacksonville, Florida, United States