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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: Clinical Trial NA study, sponsored by St. Jude Children's Research Hospital.

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, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

Descriptive statistics for number of cases replanned during treatment course will be reported

Interventions

  • RADIATION Proton Therapy (Adaptive)

Trial Details

FieldValue
Enrollment Target 100 participants
Start Date 2026-08
Est. Completion 2031-08
Phase NA

What is known before NCT07514819 opens enrollment

NCT07514819 is an interventional study that assigns participants to a tested intervention. The registered 100 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (93% lower).

The record links to 0 conditions, and to 1 intervention - of which Proton Therapy (Adaptive) is the first listed.

NCT07514819 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT07514819's enrollment target sits among peer trials

100 840th of 2000 higher than 1,081 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07514819, the US trial registry maintained by the National Library of Medicine. NCT07514819 (mid enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.