Pediatric CancerNCT04125095
Estimating Setup Uncertainty in Pediatric Proton Therapy Using Volumetric Images
An observational study of Pediatric Cancer, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
This research study establishes a repository for imaging data generated during image-guided proton therapy for various pediatric cancers. The data facilitate the estimation of patient positioning uncertainty, the comparison of image guidance methods, and the identification of factors contributing to large setup… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Cancer
- How many people
- 367 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2020to 31 Oct 2027
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric patients of all cancer types who undergo at least 5 daily treatments of proton therapy.
Who may be able to join
- Patient will receive proton therapy of ≥5 daily fractions.
- Research participant or legal guardian/representative gives written informed consent.
Who cannot join
- Unwillingness of research participant or legal guardian/representative to give written informed consent.
- If patients previously enrolled in this study and completed protocol-specified imaging scans but return for re-irradiation, they will not be eligible to participate again.
Trial locations and contacts
1 site in 1 country.
United States1 site
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
About this study
This research study establishes a repository for imaging data generated during image-guided proton therapy for various pediatric cancers. The data facilitate the estimation of patient positioning uncertainty, the comparison of image guidance methods, and the identification of factors contributing to large setup deviations to improve the accuracy of radiation therapy in the future.
Primary Objective
Read more
To establish a repository of imaging data acquired during the radiation therapy course with linked radiation treatment plans and clinical information from pediatric patients of all cancer types receiving image-guided proton therapy to facilitate secondary and exploratory objectives.
Secondary Objectives
- To estimate distributions of patient setup uncertainty measured with daily pre- treatment volumetric cone beam computed tomography (CBCT) scans.
- To compare patient setup corrections derived based on 2D (orthogonal radiographs) and 3D (volumetric CBCT scans) image guidance.
- To assess residual setup errors after CBCT-guided correction based on post- correction repeat CBCT.
- To estimate distributions and time trends of patient motion during a radiation therapy course based on weekly pre- and post-treatment CBCT scans.
- To identify clinical and treatment factors that contribute to significantly large setup uncertainty and intra-fractional movement in pediatric patients.
Exploratory Objectives
- To determine variation in patient anatomy using images acquired during the treatment course.
- To evaluate the usefulness of on-treatment CBCT scans for detecting daily changes in proton ranges, evaluating deviations from planned tumor dosimetry, and triggering adaptive replanning.
Read the detailed description
Image guidance data collected in this study include daily volumetric pre-treatment CBCT for image guidance, post-correction CBCT, weekly post-treatment CBCT, and 2D orthogonal radiographs. Setup uncertainty will be estimated for head and body cohorts separately, further divided into different anatomic sites. The usefulness and necessity of daily volumetric image guidance for pediatric proton therapy patients will be determined. Knowledge gained from this study will provide a basis for reducing patient positioning uncertainty and designing optimal treatment plans for pediatric patients receiving proton therapy.
- Conditions
- Pediatric Cancer
- Keywords
- Proton therapy, Children and adolescents, Image guidance, Setup uncertainty
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Head Scans | Includes patients receiving proton therapy for tumors in the brain, skull, and head and neck region. The same patient could potentially contribute to both cohorts if he/she receives radiation to both head and body sites. | |
| Body Scans | Includes proton irradiation to shoulders, thorax, abdomen, pelvis, spine (thoracic or lumbar), extremities, and other body sites. The same patient could potentially contribute to both cohorts if he/she receives radiation to both head and body sites. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Site-specific distributions of patient setup uncertainty.
The numbers of subjects enrolled in the head cohort and the body cohort.
Measured: 5 years after activation
Secondary outcomes (6)
Differences in setup errors calculated from orthogonal radiographs and cone beam computed tomography (CBCT)
This is to determine if setup corrections estimated from orthogonal radiographs are similar to those from volumetric imaging. The differences of each positional shift (x, y, z, pitch, roll, yaw) are measured.
Measured: 5 years
Residual errors after image-guided setup corrections
This is to determine if residual setup errors are submillimeter after image guidance with robotic cone beam computed tomography and 6 degree-of-freedom patient positioner. Residual errors differences for six parameters (x, y, z, pitch, roll, yaw) are measured.
Measured: 5 years
Distributions of intra-fractional patient motion
This is to estimate the change in patient position during a treatment fraction based on pre- and post-fractional volumetric imaging. The differences of each positional shift (x, y, z, pitch, roll, yaw) are measured.
Measured: 5 years
Risk factors of large setup uncertainty and intra-fractional movement
Risk factors (e.g., age, anesthesia, and anatomic site) that associate with the significantly large setup uncertainty and intra-fractional movement will be identified. The association with p value between age and setup uncertainty is measured.
Measured: 5 years
Risk factors of large setup uncertainty and intra-fractional movement
Risk factors (e.g., age, anesthesia, and anatomic site) that associate with the significantly large setup uncertainty and intra-fractional movement will be identified. The association with p value between anesthesia and setup uncertainty is measured.
Measured: 5 years
Risk factors of large setup uncertainty and intra-fractional movement
Risk factors (e.g., age, anesthesia, and anatomic site) that associate with the significantly large setup uncertainty and intra-fractional movement will be identified. The association with p value between anatomic site and setup uncertainty is measured.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2019
- Study start28 Jan 2020
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric CancerStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- 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
- 367 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Chia-ho Hua, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04125095
- Sponsor's protocol ID
- SJPROTON2
- Status last verified
- Jun 2026
- First submitted
- 10 Oct 2019
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Becksfort J, Uh J, Saunders A, Byrd JA, Worrall HM, Marker M, Melendez-Suchi C, Li Y, Chang J, Raghavan K, Merchant TE, Hua CH. Setup Uncertainty of Pediatric Brain Tumor Patients Receiving Proton Therapy: A Prospective Study. Cancers (Basel). 2023 Nov 20;15(22):5486. doi: 10.3390/cancers15225486.
PubMed 38001746
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Estimating Setup Uncertainty in Pediatric Proton Therapy Using Volumetric Images
- ClinicalTrials.gov ID
- NCT04125095
- Acronym / sponsor ID
- SJPROTON2
- Conditions
- Pediatric Cancer
- Keywords
- Proton therapy, Children and adolescents, Image guidance, Setup uncertainty
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 367 participants (actual)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 28 Jan 2020 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 14 Oct 2019 (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.
This research study establishes a repository for imaging data generated during image-guided proton therapy for various pediatric cancers. The data facilitate the estimation of patient positioning uncertainty, the comparison of image guidance methods, and the identification of factors contributing to large setup deviations to improve the accuracy of radiation therapy in the future.
Primary Objective
To establish a repository of imaging data acquired during the radiation therapy course with linked radiation treatment plans and clinical information from pediatric patients of all cancer types receiving image-guided proton therapy to facilitate secondary and exploratory objectives.
Secondary Objectives
- To estimate distributions of patient setup uncertainty measured with daily pre- treatment volumetric cone beam computed tomography (CBCT) scans.
- To compare patient setup corrections derived based on 2D (orthogonal radiographs) and 3D (volumetric CBCT scans) image guidance.
- To assess residual setup errors after CBCT-guided correction based on post- correction repeat CBCT.
- To estimate distributions and time trends of patient motion during a radiation therapy course based on weekly pre- and post-treatment CBCT scans.
- To identify clinical and treatment factors that contribute to significantly large setup uncertainty and intra-fractional movement in pediatric patients.
Exploratory Objectives
- To determine variation in patient anatomy using images acquired during the treatment course.
- To evaluate the usefulness of on-treatment CBCT scans for detecting daily changes in proton ranges, evaluating deviations from planned tumor dosimetry, and triggering adaptive replanning.
Detailed description
Image guidance data collected in this study include daily volumetric pre-treatment CBCT for image guidance, post-correction CBCT, weekly post-treatment CBCT, and 2D orthogonal radiographs. Setup uncertainty will be estimated for head and body cohorts separately, further divided into different anatomic sites. The usefulness and necessity of daily volumetric image guidance for pediatric proton therapy patients will be determined. Knowledge gained from this study will provide a basis for reducing patient positioning uncertainty and designing optimal treatment plans for pediatric patients receiving proton therapy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Head Scans | – | –Includes patients receiving proton therapy for tumors in the brain, skull, and head and neck region. The same patient could potentially contribute to both cohorts if he/she receives radiation to both head and body sites. |
| Body Scans | – | –Includes proton irradiation to shoulders, thorax, abdomen, pelvis, spine (thoracic or lumbar), extremities, and other body sites. The same patient could potentially contribute to both cohorts if he/she receives radiation to both head and body sites. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric patients of all cancer types who undergo at least 5 daily treatments of proton therapy.
Key inclusion criteria (2 listed)
- Patient will receive proton therapy of ≥5 daily fractions.
- Research participant or legal guardian/representative gives written informed consent.
Key exclusion criteria (2 listed)
- Unwillingness of research participant or legal guardian/representative to give written informed consent.
- If patients previously enrolled in this study and completed protocol-specified imaging scans but return for re-irradiation, they will not be eligible to participate again.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Site-specific distributions of patient setup uncertainty.
Time frame: 5 years after activation
The numbers of subjects enrolled in the head cohort and the body cohort.
6 secondary outcomes
Differences in setup errors calculated from orthogonal radiographs and cone beam computed tomography (CBCT)
Time frame: 5 years
Residual errors after image-guided setup corrections
Time frame: 5 years
Distributions of intra-fractional patient motion
Time frame: 5 years
Risk factors of large setup uncertainty and intra-fractional movement
Time frame: 5 years
Risk factors of large setup uncertainty and intra-fractional movement
Time frame: 5 years
Risk factors of large setup uncertainty and intra-fractional movement
Time frame: 5 years
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 17 Jun 2026.
- Background: PubMed 38001746Becksfort J, Uh J, Saunders A, Byrd JA, Worrall HM, Marker M, Melendez-Suchi C, Li Y, Chang J, Raghavan K, Merchant TE, Hua CH. Setup Uncertainty of Pediatric Brain Tumor Patients Receiving Proton Therapy: A Prospective Study. Cancers (Basel). 2023 Nov 20;15(22):5486. doi: 10.3390/cancers15225486.
- St. Jude Children's Research HospitalLink provided by the sponsor.
- Clinical Trials Open at St. JudeLink provided by the sponsor.
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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. This study is not recruiting at the moment.
Chia-ho Hua, PhD principal investigator
St. Jude Children's Research Hospital
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 Pediatric Cancer, run by St. Jude Children's Research Hospital 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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 17 Jun 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Site-specific distributions of patient setup uncertainty. (time frame: 5 years after activation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04125095, which also lists 1 linked publication.
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 17 Jun 2026.