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NCT04125095Active, not recruiting

Estimating Setup Uncertainty in Pediatric Proton Therapy Using Volumetric Images

Source: ClinicalTrials.gov · Last updated 17 Jun 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Observational
Enrollment
367 (actual)
First submitted
10 Oct 2019
Start date
28 Jan 2020
Primary completion date
31 Oct 2027
Lead sponsor
St. Jude Children's Research Hospital
NCT number
NCT04125095

What you commit to

  • Study type: Observational
  • Participants enrolled: 367
  • From 28 Jan 2020 to the primary completion date, 31 Oct 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • If patients previously enrolled in this study and completed protocol-specified imaging scans but return for re-irradiation, they will not be eligible to participate again.

Other

  • Unwillingness of research participant or legal guardian/representative to give written informed consent.

Who the study is looking for

  • Patient will receive proton therapy of ≥5 daily fractions.
  • Research participant or legal guardian/representative gives written informed consent.

Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
St. Jude Children's Research Hospital
Coordinator of this site? Confirm its status
MemphisUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.