Recruiting

Proton Therapy

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07514819

Conditions

Pediatric Solid Tumors

Rhabdomyosarcoma

Ewing Sarcoma

Osteosarcoma

Hodgkin Lymphoma

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Proton Therapy (Adaptive)

Study Details

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.

Conditions

Pediatric Solid Tumors

Rhabdomyosarcoma

Ewing Sarcoma

Osteosarcoma

Hodgkin Lymphoma

Study ID

NCT07514819

Start date

Aug 20, 2026

Status verified date

Aug, 2026

Completion date

Aug, 2031

Anticipated

Primary completion date

Aug, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Adaptive Proton Therapy With Systematic On Therapy Imaging

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.

Interventions

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 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) ]
  • 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) ]
  • 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) ]

Central Contacts and Locations

Central contacts

Ozgur Ates, PhD

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Ozgur Ates, PhD

888-226-4343referralinfo@stjude.org

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-09. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-08-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.