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NCT04125095 · ClinicalTrials.gov registry record
Estimating Setup Uncertainty in Pediatric Proton Therapy Using Volumetric Images
A clinical trial of Pediatric Cancer, sponsored by St. Jude Children's Research Hospital.
- Active
- Registry status
- 367
- Enrollment target
- 1
- Study location
NCT04125095: Active study of Pediatric Cancer, sponsored by St. Jude Children's Research Hospital.
NCT04125095 is a study of Pediatric Cancer that is active but no longer recruiting, run by St. Jude Children's Research Hospital. The registered enrollment target is 367 participants, below the 1,483-participant average among 51 other Pediatric Cancer trials with a reported enrollment target (75% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04125095, a study of Pediatric Cancer, is active but no longer recruiting, sponsored by St. Jude Children's Research Hospital.
- ACTIVE NOT RECRUITING
- Registry status
- 367 participants
- Enrollment target
- 1
- Study location
Study Summary
This research study establishes a repository for imaging data generated during image-guided proton therapy for various pediatric cancers. The data facilitate the estimation of patient positioning uncertainty, the comparison of image guidance methods, and the identification of factors contributing to large setup deviations to improve the accuracy of radiation therapy in the future. Primary Objective To establish a repository of imaging data acquired during the radiation therapy course with linked radiation treatment plans and clinical information from pediatric patients of all cancer types receiving image-guided proton therapy to facilitate secondary and exploratory objectives. Secondary Objectives * To estimate distributions of patient setup uncertainty measured with daily pre- treatment volumetric cone beam computed tomography (CBCT) scans. * To compare patient setup corrections derived based on 2D (orthogonal radiographs) and 3D (volumetric CBCT scans) image guidance. * To assess residual setup errors after CBCT-guided correction based on post- correction repeat CBCT. * To estimate distributions and time trends of patient motion during a radiation therapy course based on weekly pre- and post-treatment CBCT scans. * To identify clinical and treatment factors that contribute to significantly large setup uncertainty and intra-fractional movement in pediatric patients. Exploratory Objectives * To determine variation in patient anatomy using images acquired during the treatment course. * To evaluate the usefulness of on-treatment CBCT scans for detecting daily changes in proton ranges, evaluating deviations from planned tumor dosimetry, and triggering adaptive replanning.
Primary Outcome
The numbers of subjects enrolled in the head cohort and the body cohort.
Conditions Studied
Study Locations (1)
Tennessee
- St. Jude Children's Research Hospital - Memphis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 367 participants |
| Start Date | 2020-01-28 |
| Est. Completion | 2027-10-31 |
What the registry record for NCT04125095 still lists
NCT04125095 is an observational study that tracks outcomes without assigning an intervention. The registered 367 participants enrollment target is mid-sized for trials with a published cap, below the 1,483-participant average among 51 other Pediatric Cancer trials with a reported enrollment target (75% lower).
The record links to 1 condition, with Pediatric Cancer appearing as the primary indexed condition, and to 0 interventions.
NCT04125095 reports a single indexed study location in Tennessee.
Frequently Asked Questions
What is clinical trial NCT04125095 about?
NCT04125095 is a clinical study titled "Estimating Setup Uncertainty in Pediatric Proton Therapy Using Volumetric Images". This research study establishes a repository for imaging data generated during image-guided proton therapy for various pediatric cancers. The data facilitate the estimation of patient positioning uncertainty, the comparison of image guidance methods, and the identification of factors contributing to...
What is the current status of trial NCT04125095?
This trial is currently active not recruiting. The enrollment target is 367 participants. The study started on 2020-01-28. Estimated completion is 2027-10-31.
What conditions does trial NCT04125095 study?
This clinical trial studies the following conditions: Pediatric Cancer.
Who is sponsoring clinical trial NCT04125095?
This trial is sponsored by St. Jude Children's Research Hospital, which has 410 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04125095 being conducted?
This trial has 1 study location across Tennessee. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Pediatric Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT04125095's enrollment target sits among peer trials
367 11th of 51 higher than 41 of 51 other Pediatric Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Pediatric Cancer 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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