Proton TherapyNCT07832617
Protoacoustic Imaging For 3D Mapping
An observational study of Proton Therapy and Radiation Therapy, Secondary Skin Reactions, run by University of Oklahoma at 1 site in United States.
Trial summary
The purpose of this study is to test a new imaging technology called radioacoustic imaging (RAI) that may help doctors see where radiation is being delivered during proton therapy. During proton therapy, the radiation treatment produces very small sound signals inside the body. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Proton Therapy, Radiation Therapy, Secondary Skin Reactions, Liver Cancer
- What is being tested?
- Radiacoustic Imaging w/Ultrasound.
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jun 2026to Jun 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Recruitment will be for prostate and liver cancer patients only.
Who may be able to join
- Patients at least >18years old
- Patients referred to OUHSC SCC for SOC PT
- Patients receiving treatment for indications where RAI data collection is feasible (e.g., liver and prostate)
- Willingness and ability to provide a documented informed consent
Who cannot join
- Patients with contraindications for ultrasound coupling (e.g., extensive open wounds or skin conditions at transducer placement sites).
- Patients whose treatment plan or setup prevents the practical application of the RAI system without interfering with standard clinical care
- Patients with implanted electronic devices (e.g., pacemakers) in the treatment region if there is any concern of device interference, even though the RAI system is passive.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73117
Yong Chen, PhD, 405-271-3016, Yong-Chen@ou.edu
About this study
Official title: Protoacoustic Imaging for 3D Mapping the Bragg Peak in Real Time During Proton Therapy (PROTEUS)
The purpose of this study is to test a new imaging technology called radioacoustic imaging (RAI) that may help doctors see where radiation is being delivered during proton therapy.
During proton therapy, the radiation treatment produces very small sound signals inside the body. This study will use special ultrasound sensors placed on the outside of the body to detect these signals. The information collected may allow researchers to create a picture showing where the radiation dose is being delivered in the body and how much radiation is reaching the treatment area.
The goal is to determine whether this technology can safely and accurately measure radiation during proton therapy without requiring any additional procedures or radiation exposure.
Read the detailed description
Radiation therapy is a cornerstone of cancer treatment, and proton therapy offers enhanced precision for treating deep-seated tumors due to the Bragg Peak phenomenon, which allows for concentrated dose delivery while minimizing exposure to surrounding healthy tissue. This study seeks to build upon this advantage by incorporating real-time, in vivo verification of proton dose deposition. The study hypothesizes that integrating RAI with ultrasound (US) will enable real-time dose verification and motion tracking, thereby improving the accuracy, adaptability, and overall effectiveness of proton therapy for moving targets such as the liver and prostate.
Participants enrolled in the study will first undergo standard X-ray alignment as part of their routine treatment workflow. Following alignment, a robotic arm will position an ultrasound matrix array over the lower anterior abdominal region. A conformal, water-mediated interface in combination with ultrasound gel will be used to ensure optimal acoustic coupling between the transducer and the patient's skin, allowing for passive detection of acoustic signals generated during proton beam delivery. These signals will be used to reconstruct and monitor dose deposition in real time throughout treatment.
- Conditions
- Proton Therapy, Radiation Therapy, Secondary Skin Reactions, Liver Cancer, Prostate Cancer
- Being tested
- Radiacoustic Imaging w/Ultrasound.
- Keywords
- RAI
- Medical subject headings
- Liver Neoplasms, Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiacoustic Imaging w/Ultrasound.Device
A robotic arm will position the ultrasound matrix array on the lower abdomen.
| Study group | Role | What they receive |
|---|---|---|
| Proton Therapy In Vivo | This prospective clinical trial will evaluate the use of RAI in 24 cancer patients, including 12 patients with liver cancer and 12 patients with prostate cancer, using a noninvasive device. The device consists of a small ultrasound transducer placed on the participant's body that delivers low-intensity sound signals through the body to evaluate the treatment. Receives: Device: Radiacoustic Imaging w/Ultrasound. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Liver Cancer Patients With Successful Respiratory Motion From Radiacoustic Imaging Tracking.
The dual-modality Radioacoustic Imaging integrated with Ultrasound (RAI/US) system in liver cancer patients is deployed to track respiratory motion, overlay real-time dose maps on ultrasound anatomy, and integrate adaptive feedback into the treatment workflow.
Measured: 1 year
Secondary outcomes (1)
Percentage of Completed Workflow Treatment Plans Using Radiacoustic Imaging With Ultrasound In Prostate Cancer Patients.
Successfully develop a time-efficient RAI/US workflow for daily prostate cancer treatments, monitoring both intra- and inter-fractional motion, and applying geometric corrections to support adaptive planning.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start10 Jun 2026
- Primary completionJun 2028 (estimated)
- Study completionJun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Proton TherapyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yong Chen, PhD, Principal investigator, University of Oklahoma - Stephenson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07832617
- Sponsor's protocol ID
- OU-SCC-PROTEUS
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 22 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protoacoustic Imaging for 3D Mapping the Bragg Peak in Real Time During Proton Therapy (PROTEUS)
- ClinicalTrials.gov ID
- NCT07832617
- Acronym / sponsor ID
- OU-SCC-PROTEUS
- Conditions
- Proton Therapy, Radiation Therapy, Secondary Skin Reactions, Liver Cancer, Prostate Cancer
- Keywords
- RAI
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- 10 Jun 2026 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2030 (estimated)
- First posted
- 22 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test a new imaging technology called radioacoustic imaging (RAI) that may help doctors see where radiation is being delivered during proton therapy.
During proton therapy, the radiation treatment produces very small sound signals inside the body. This study will use special ultrasound sensors placed on the outside of the body to detect these signals. The information collected may allow researchers to create a picture showing where the radiation dose is being delivered in the body and how much radiation is reaching the treatment area.
The goal is to determine whether this technology can safely and accurately measure radiation during proton therapy without requiring any additional procedures or radiation exposure.
Detailed description
Radiation therapy is a cornerstone of cancer treatment, and proton therapy offers enhanced precision for treating deep-seated tumors due to the Bragg Peak phenomenon, which allows for concentrated dose delivery while minimizing exposure to surrounding healthy tissue. This study seeks to build upon this advantage by incorporating real-time, in vivo verification of proton dose deposition. The study hypothesizes that integrating RAI with ultrasound (US) will enable real-time dose verification and motion tracking, thereby improving the accuracy, adaptability, and overall effectiveness of proton therapy for moving targets such as the liver and prostate.
Participants enrolled in the study will first undergo standard X-ray alignment as part of their routine treatment workflow. Following alignment, a robotic arm will position an ultrasound matrix array over the lower anterior abdominal region. A conformal, water-mediated interface in combination with ultrasound gel will be used to ensure optimal acoustic coupling between the transducer and the patient's skin, allowing for passive detection of acoustic signals generated during proton beam delivery. These signals will be used to reconstruct and monitor dose deposition in real time throughout treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Proton Therapy In Vivo | – | Device: Radiacoustic Imaging w/Ultrasound.This prospective clinical trial will evaluate the use of RAI in 24 cancer patients, including 12 patients with liver cancer and 12 patients with prostate cancer, using a noninvasive device. The device consists of a small ultrasound transducer placed on the participant's body that delivers low-intensity sound signals through the body to evaluate the treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Recruitment will be for prostate and liver cancer patients only.
Key inclusion criteria (4 listed)
- Patients at least >18years old
- Patients referred to OUHSC SCC for SOC PT
- Patients receiving treatment for indications where RAI data collection is feasible (e.g., liver and prostate)
- Willingness and ability to provide a documented informed consent
Key exclusion criteria (3 listed)
- Patients with contraindications for ultrasound coupling (e.g., extensive open wounds or skin conditions at transducer placement sites).
- Patients whose treatment plan or setup prevents the practical application of the RAI system without interfering with standard clinical care
- Patients with implanted electronic devices (e.g., pacemakers) in the treatment region if there is any concern of device interference, even though the RAI system is passive.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiacoustic Imaging w/Ultrasound.A robotic arm will position the ultrasound matrix array on the lower abdomen. | Device | Proton Therapy In Vivo |
Primary outcome
Percentage of Liver Cancer Patients With Successful Respiratory Motion From Radiacoustic Imaging Tracking.
Time frame: 1 year
The dual-modality Radioacoustic Imaging integrated with Ultrasound (RAI/US) system in liver cancer patients is deployed to track respiratory motion, overlay real-time dose maps on ultrasound anatomy, and integrate adaptive feedback into the treatment workflow.
1 secondary outcome
Percentage of Completed Workflow Treatment Plans Using Radiacoustic Imaging With Ultrasound In Prostate Cancer Patients.
Time frame: 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yong Chen, PhD principal investigator
University of Oklahoma - Stephenson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Proton Therapy and Radiation Therapy, Secondary Skin Reactions, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lead Onco Nurse ((405) 271-3016, SCC-IIT-Office@ouhsc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Liver Cancer Patients With Successful Respiratory Motion From Radiacoustic Imaging Tracking. (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.