Pediatric Solid TumorsNCT07514819
Integration of Adaptive Proton Therapy in Pediatric Solid Tumors and Hodgkin's Lymphoma
A study testing Proton Therapy (Adaptive) in people with Pediatric Solid Tumors and Rhabdomyosarcoma, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial summary
Pediatric patients receiving proton therapy for solid tumors or Hodgkin's lymphoma may experience anatomical changes during treatment that can affect proton therapy accuracy. This prospective single-arm study uses regular low-dose imaging to monitor these changes and adjust treatment plans as needed. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Pediatric Solid Tumors, Rhabdomyosarcoma, Ewing Sarcoma
- What is being tested?
- Proton Therapy (Adaptive)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2026to Aug 2031
- Phase
- Interventional
- 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
Who may be able to join
- Participants diagnosed with solid tumors, including Rhabdomyosarcoma, Osteosarcoma, Ewing sarcoma, other sarcomas and carcinomas or also Hodgkin's lymphoma.
- Participants who receive proton radiation therapy at St. Jude Children's Research Hospital.
- Research participant or legal guardian/representative gives written informed consent.
Who cannot join
- Participants who are not diagnosed with solid tumors or Hodgkin's lymphoma.
- Participants who are diagnosed with Wilm's tumor or neuroblastoma
- Participants who do not undergo proton therapy.
- Participants who are prescribed equal or less than 5 fractions of proton therapy.
- Participants with severe comorbid conditions that may impact imaging feasibility.
- Inability to obtain written consent from research participant or legal guardian/representative.
- Females of child-bearing potential cannot be pregnant or breast-feeding. Female participants >10 years of age or post-menarchal must have a negative serum or urine pregnancy test
- All participants receiving proton therapy at St. Jude Children's Research Hospital will be screened for participation on this research protocol based on the Inclusion Criteria and the Exclusion Criteria. Qualified candidates will be selected during the consultation.
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
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105
Ozgur Ates, PhD, 888-226-4343, referralinfo@stjude.org
About this study
Pediatric patients receiving proton therapy for solid tumors or Hodgkin's lymphoma may experience anatomical changes during treatment that can affect proton therapy accuracy. This prospective single-arm study uses regular low-dose imaging to monitor these changes and adjust treatment plans as needed. Participants will receive weekly or every-other-week CT scans, with MRI when appropriate, to assess whether the original plan remains accurate. Treatment plans will be updated if tumor coverage decreases by more than 5% or if radiation dose to normal tissues increases by more than 10%; otherwise, the original plan will continue. The study aims to determine how often plan adjustments are needed and to identify which disease sites are most likely to experience significant anatomical changes during treatment.
Primary Objective:
Read more
- Define the frequency of replanning necessary to ensure tumor coverage never falls below 95% (or 5% drop) of the prescribed daily dose in participants with intact (gross) tumors to keep the tumor control optimal throughout the multi-week treatment regimen.
- Define the frequency of replanning necessary to ensure organs-at-risk (critical organs) do not deviate by more than 10% of the initially approved dose constraints to keep the normal tissue complication minimal throughout the multi-week treatment regimen.
Secondary Objectives
- Establish a cone beam CT (CBCT)-based framework for quantifying body surface changes throughout the treatment course. This goal will be achieved by developing a novel algorithm that detects and tracks external anatomical variations longitudinally, without requiring CBCT image enhancement, enabling precise assessment of daily participant setup consistency and anatomical stability.
- Overcome daily CBCT quality limitations by generating synthetic CT images that accurately represent daily anatomy and support proton dose recalculation or verification planning. This goal will be achieved by developing a hybrid pipeline that integrates deep learning models with the deformable image registration algorithm, trained and validated on disease site-specific data. This will enable precise dose mapping and tissue density estimation, directly supporting adaptive planning decisions without the need of diagnostic- quality CT images.
Read the detailed description
Proton therapy is a type of radiation treatment that can target tumors very precisely while protecting healthy organs. This is especially important for children. However, during the several weeks of treatment, a child's body and tumor can change. These changes may cause the radiation dose to miss part of the tumor or give too much dose to nearby organs.
In usual care, proton therapy plans are based on one CT scan taken before treatment starts. New scans are only done if the care team thinks a change has occurred. There is no standard process to regularly check whether the treatment plan is still accurate during therapy.
This study tests a structured approach to monitoring and adjusting proton therapy plans during treatment in children with solid tumors or Hodgkin's lymphoma.
About 100 pediatric patients receiving proton therapy at St. Jude Children's Research Hospital will take part. All patients will receive their prescribed proton therapy as usual. The study does not change the radiation dose or schedule.
Participants will receive additional CT scans, and MRI when needed, during treatment. Imaging will be done weekly or every other week to check whether the original treatment plan still provides good tumor coverage and protects healthy organs.
The treatment plan will be updated if:
- Tumor coverage drops by more than 5%, or
- Radiation dose to normal organs increases by 10% or more.
If these changes are not seen, the original plan will continue. The extra imaging uses a low radiation dose.
The goal of this study is to learn how often proton therapy plans need to be adjusted to keep treatment accurate and safe. Results may help improve proton therapy care for children in the future.
- Conditions
- Pediatric Solid Tumors, Rhabdomyosarcoma, Ewing Sarcoma, Osteosarcoma, Hodgkin Lymphoma, Bone Tumor
- Being tested
- Proton Therapy (Adaptive)
- Medical subject headings
- Rhabdomyosarcoma, Sarcoma, Ewing, Osteosarcoma, Hodgkin Disease, Bone Neoplasms, Sarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Proton Therapy (Adaptive)Radiation
Proton beam radiation therapy delivered per standard disease or site specific protocols, with additional on therapy CT and/or MRI imaging performed weekly or bi weekly during treatment. Verification planning is conducted using updated imaging, and treatment plans are adaptively replanned when tumor coverage decreases by ≥5% or organ at risk dose increases by ≥10% compared with the originally approved plan. Total dose, fractionation, and treatment schedule follow standard of care and are determined by the treating physician.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Proton Therapy With Systematic On Therapy Imaging | Experimental | All enrolled participants receive standard of care proton therapy combined with systematic on therapy imaging (CT and/or MRI) during treatment. Imaging is used to generate verification plans to assess dose delivery relative to the original plan. Adaptive replanning is implemented if predefined dosimetric thresholds are exceeded. Receives: Radiation: Proton Therapy (Adaptive) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Replanning Treatment
Descriptive statistics for number of cases replanned during treatment course will be reported
Measured: Captured during on-therapy imaging (occurring either weekly or bi-weekly) for the duration of the patient's treatment course (varies depending on individual cases, anywhere from roughly 6 weeks to 10 weeks)
Tumor Control Probability (TCP) and Normal Tissue Complication Probability (NTCP)
Descriptive statistics for V95% (tumor coverage) and OAR (organs-at-risk) will be reported, as well as signed-rank tests to evaluate adaptive planning effectiveness
Measured: Captured during on-therapy imaging (occurring either weekly or bi-weekly) for the duration of the patient's treatment course (varies depending on individual cases, anywhere from roughly 6 weeks to 10 weeks)
Correlation between tissue discrepancies and changes in proton range, and deviations from intended plan quality
Spearman correlation will be reported, assessing the associations between factors
Measured: Captured during on-therapy imaging (occurring either weekly or bi-weekly) for the duration of the patient's treatment course (varies depending on individual cases, anywhere from roughly 6 weeks to 10 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2026
- Study start20 Aug 2026
- Primary completionAug 2029 (estimated)
- Study completionAug 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pediatric Solid TumorsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ozgur Ates, PhD, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07514819
- Sponsor's protocol ID
- SJPROTON3
- Status last verified
- Aug 2026
- First submitted
- 31 Mar 2026
- Last updated
- 21 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integration of Adaptive Proton Therapy in Pediatric Solid Tumors and Hodgkin's Lymphoma
- ClinicalTrials.gov ID
- NCT07514819
- Acronym / sponsor ID
- SJPROTON3
- Conditions
- Pediatric Solid Tumors, Rhabdomyosarcoma, Ewing Sarcoma, Osteosarcoma, Hodgkin Lymphoma, Bone Tumor
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- St. Jude Children's Research HospitalUniversity, hospital or other
- Study start
- 20 Aug 2026 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Aug 2031 (estimated)
- First posted
- 7 Apr 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.
Pediatric patients receiving proton therapy for solid tumors or Hodgkin's lymphoma may experience anatomical changes during treatment that can affect proton therapy accuracy. This prospective single-arm study uses regular low-dose imaging to monitor these changes and adjust treatment plans as needed. Participants will receive weekly or every-other-week CT scans, with MRI when appropriate, to assess whether the original plan remains accurate. Treatment plans will be updated if tumor coverage decreases by more than 5% or if radiation dose to normal tissues increases by more than 10%; otherwise, the original plan will continue. The study aims to determine how often plan adjustments are needed and to identify which disease sites are most likely to experience significant anatomical changes during treatment.
Primary Objective:
- Define the frequency of replanning necessary to ensure tumor coverage never falls below 95% (or 5% drop) of the prescribed daily dose in participants with intact (gross) tumors to keep the tumor control optimal throughout the multi-week treatment regimen.
- Define the frequency of replanning necessary to ensure organs-at-risk (critical organs) do not deviate by more than 10% of the initially approved dose constraints to keep the normal tissue complication minimal throughout the multi-week treatment regimen.
Secondary Objectives
- Establish a cone beam CT (CBCT)-based framework for quantifying body surface changes throughout the treatment course. This goal will be achieved by developing a novel algorithm that detects and tracks external anatomical variations longitudinally, without requiring CBCT image enhancement, enabling precise assessment of daily participant setup consistency and anatomical stability.
- Overcome daily CBCT quality limitations by generating synthetic CT images that accurately represent daily anatomy and support proton dose recalculation or verification planning. This goal will be achieved by developing a hybrid pipeline that integrates deep learning models with the deformable image registration algorithm, trained and validated on disease site-specific data. This will enable precise dose mapping and tissue density estimation, directly supporting adaptive planning decisions without the need of diagnostic- quality CT images.
Detailed description
Proton therapy is a type of radiation treatment that can target tumors very precisely while protecting healthy organs. This is especially important for children. However, during the several weeks of treatment, a child's body and tumor can change. These changes may cause the radiation dose to miss part of the tumor or give too much dose to nearby organs.
In usual care, proton therapy plans are based on one CT scan taken before treatment starts. New scans are only done if the care team thinks a change has occurred. There is no standard process to regularly check whether the treatment plan is still accurate during therapy.
This study tests a structured approach to monitoring and adjusting proton therapy plans during treatment in children with solid tumors or Hodgkin's lymphoma.
About 100 pediatric patients receiving proton therapy at St. Jude Children's Research Hospital will take part. All patients will receive their prescribed proton therapy as usual. The study does not change the radiation dose or schedule.
Participants will receive additional CT scans, and MRI when needed, during treatment. Imaging will be done weekly or every other week to check whether the original treatment plan still provides good tumor coverage and protects healthy organs.
The treatment plan will be updated if:
- Tumor coverage drops by more than 5%, or
- Radiation dose to normal organs increases by 10% or more.
If these changes are not seen, the original plan will continue. The extra imaging uses a low radiation dose.
The goal of this study is to learn how often proton therapy plans need to be adjusted to keep treatment accurate and safe. Results may help improve proton therapy care for children in the future.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive Proton Therapy With Systematic On Therapy Imaging | Experimental | Radiation: Proton Therapy (Adaptive)All enrolled participants receive standard of care proton therapy combined with systematic on therapy imaging (CT and/or MRI) during treatment. Imaging is used to generate verification plans to assess dose delivery relative to the original plan. Adaptive replanning is implemented if predefined dosimetric thresholds are exceeded. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participants diagnosed with solid tumors, including Rhabdomyosarcoma, Osteosarcoma, Ewing sarcoma, other sarcomas and carcinomas or also Hodgkin's lymphoma.
- Participants who receive proton radiation therapy at St. Jude Children's Research Hospital.
- Research participant or legal guardian/representative gives written informed consent.
Key exclusion criteria (8 listed)
- Participants who are not diagnosed with solid tumors or Hodgkin's lymphoma.
- Participants who are diagnosed with Wilm's tumor or neuroblastoma
- Participants who do not undergo proton therapy.
- Participants who are prescribed equal or less than 5 fractions of proton therapy.
- Participants with severe comorbid conditions that may impact imaging feasibility.
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 |
|---|---|---|
| Proton Therapy (Adaptive)Proton beam radiation therapy delivered per standard disease or site specific protocols, with additional on therapy CT and/or MRI imaging performed weekly or bi weekly during treatment. Verification planning is conducted using updated imaging, and treatment plans are adaptively replanned when tumor coverage decreases by ≥5% or organ at risk dose increases by ≥10% compared with the originally approved plan. Total dose, fractionation, and treatment schedule follow standard of care and are determined by the treating physician. | Radiation | Adaptive Proton Therapy With Systematic On Therapy Imaging |
Primary outcome
Rate of Replanning Treatment
Time frame: Captured during on-therapy imaging (occurring either weekly or bi-weekly) for the duration of the patient's treatment course (varies depending on individual cases, anywhere from roughly 6 weeks to 10 weeks)
Descriptive statistics for number of cases replanned during treatment course will be reported
Tumor Control Probability (TCP) and Normal Tissue Complication Probability (NTCP)
Time frame: Captured during on-therapy imaging (occurring either weekly or bi-weekly) for the duration of the patient's treatment course (varies depending on individual cases, anywhere from roughly 6 weeks to 10 weeks)
Descriptive statistics for V95% (tumor coverage) and OAR (organs-at-risk) will be reported, as well as signed-rank tests to evaluate adaptive planning effectiveness
Correlation between tissue discrepancies and changes in proton range, and deviations from intended plan quality
Time frame: Captured during on-therapy imaging (occurring either weekly or bi-weekly) for the duration of the patient's treatment course (varies depending on individual cases, anywhere from roughly 6 weeks to 10 weeks)
Spearman correlation will be reported, assessing the associations between factors
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 21 Aug 2026.
- 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.
Ozgur Ates, 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?
A study testing Proton Therapy (Adaptive) in people with Pediatric Solid Tumors and Rhabdomyosarcoma, 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 3 inclusion and 8 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 21 Aug 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 Ozgur Ates, PhD (888-226-4343, referralinfo@stjude.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Replanning Treatment (time frame: Captured during on-therapy imaging (occurring either weekly or bi-weekly) for the duration of the patient's treatment course (varies depending on individual cases, anywhere from roughly 6 weeks to 10 weeks)). The study lists 3 primary outcomes in all. 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 21 Aug 2026.