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NCT07514819 · ClinicalTrials.gov registry record · NA
Integration of Adaptive Proton Therapy in Pediatric Solid Tumors and Hodgkin's Lymphoma
A NA study, sponsored by St. Jude Children's Research Hospital.
- Not yet
- Registry status
- NA
- Development phase
- 100
- Enrollment target
NCT07514819 is a NA study that has not yet begun recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 100 participants.
The verdict
NCT07514819, a NA study, has not yet begun recruiting, sponsored by St. Jude Children's Research Hospital.
- NOT YET RECRUITING
- Registry status
- NA
- Development phase
- 100 participants
- Enrollment target
Study 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 tha
Interventions
- RADIATION Proton Therapy (Adaptive)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 100 participants |
| Start Date | 2026-08 |
| Est. Completion | 2031-08 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07514819
The ClinicalTrials.gov registry entry for NCT07514819 describes a study currently listed as not yet recruiting, categorized as NA. The registered enrollment target is 100 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is St. Jude Children's Research Hospital, which has 410 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Proton Therapy (Adaptive) is the first listed.
NCT07514819 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07514819 about?
NCT07514819 is a clinical study titled "Integration of Adaptive Proton Therapy in Pediatric Solid Tumors and Hodgkin's Lymphoma". 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...
What is the current status of trial NCT07514819?
This trial is currently not yet recruiting. It is a NA study. The enrollment target is 100 participants. The study started on 2026-08. Estimated completion is 2031-08.
What interventions are being tested in trial NCT07514819?
The interventions under investigation include: Proton Therapy (Adaptive) (RADIATION).
Who is sponsoring clinical trial NCT07514819?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
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