NCT07514819 · St. Jude Children's Research Hospital
Integration of Adaptive Proton Therapy in Pediatric Solid Tumors and Hodgkin's Lymphoma
What this study is about
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 forward-looking single-treatment group$1 study uses regular low-dose imaging to monitor these changes and adjust treatment plans as needed.
View original scientific description
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.
Interventions
RADIATION
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.
Primary outcome measures
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
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- 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.
Where
- Memphis, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Aug 21, 2026 · Source of record for eligibility and locations