NCT07514819 Integration of Adaptive Proton Therapy in Pediatric Solid Tumors and Hodgkin's Lymphoma
| NCT ID | NCT07514819 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Jude Children's Research Hospital |
| Condition | Pediatric Solid Tumors |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2026-08-20 |
| Primary Completion | 2029-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 100 participants in total. It began in 2026-08-20 with a primary completion date of 2029-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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. 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.
Eligibility Criteria
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.
Contact & Investigator
Ozgur Ates, PhD
PRINCIPAL INVESTIGATOR
St. Jude Children's Research Hospital
Frequently Asked Questions
Who can join the NCT07514819 clinical trial?
This trial is open to participants of all sexes, studying Pediatric Solid Tumors. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07514819 currently recruiting?
Yes, NCT07514819 is actively recruiting participants. Contact the research team at referralinfo@stjude.org for enrollment information.
Where is the NCT07514819 trial being conducted?
This trial is being conducted at Memphis, United States.
Who is sponsoring the NCT07514819 clinical trial?
NCT07514819 is sponsored by St. Jude Children's Research Hospital. The principal investigator is Ozgur Ates, PhD at St. Jude Children's Research Hospital. The trial plans to enroll 100 participants.