Clinical trial · Observational
Estimating Setup Uncertainty in Pediatric Proton Therapy Using Volumetric Images
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- Head Scans
- description
- Includes patients receiving proton therapy for tumors in the brain, skull, and head and neck region. The same patient could potentially contribute to both cohorts if he/she receives radiation to both head and body sites.
- label
- Body Scans
- description
- Includes proton irradiation to shoulders, thorax, abdomen, pelvis, spine (thoracic or lumbar), extremities, and other body sites. The same patient could potentially contribute to both cohorts if he/she receives radiation to both head and body sites.
Primary outcomes (1)
- measure
- Site-specific distributions of patient setup uncertainty.
- timeFrame
- 5 years after activation
- description
- The numbers of subjects enrolled in the head cohort and the body cohort.
Secondary outcomes (6)
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: * Patient will receive proton therapy of ≥5 daily fractions. * Research participant or legal guardian/representative gives written informed consent. Exclusion Criteria: * Unwillingness of research participant or legal guardian/representative to give written informed consent. * 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.
References
Publications (1)
- BACKGROUNDBecksfort J, Uh J, Saunders A, Byrd JA, Worrall HM, Marker M, Melendez-Suchi C, Li Y, Chang J, Raghavan K, Merchant TE, Hua CH. Setup Uncertainty of Pediatric Brain Tumor Patients Receiving Proton Therapy: A Prospective Study. Cancers (Basel). 2023 Nov 20;15(22):5486. doi: 10.3390/cancers15225486. PMID 38001746