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

University of Florida

Status: Enrolling

Conditions: Prostate Cancer

Treatments: Device: iRAI

Study type: Interventional

Funder types: Other

Identifiers

NCT06465966

IRB202400573

Details and patient eligibility

About

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

Enrollment: 30 estimated patients

Sex: Male

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

iRAI data collection

Experimental group

Description:

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.

Treatment:

Device: iRAI