Estimating Setup Uncertainty in Pediatric Proton Therapy Using Volumetric Images

NCT04125095 | Active Not Recruiting

• 1 other identifier: SJPROTON2
• Study Type: observational
• Target: 367
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Pediatric Cancer

Keywords

Proton therapy, Children and adolescents, Image guidance, Setup uncertainty

Outcome Measures

Primary Outcomes (1)

• Site-specific distributions of patient setup uncertainty.

  The numbers of subjects enrolled in the head cohort and the body cohort.

  5 years after activation

Secondary Outcomes (6)

• Differences in setup errors calculated from orthogonal radiographs and cone beam computed tomography (CBCT)

  5 years

• Residual errors after image-guided setup corrections

  5 years

• Distributions of intra-fractional patient motion

  5 years

• Risk factors of large setup uncertainty and intra-fractional movement

  5 years

• Risk factors of large setup uncertainty and intra-fractional movement

  5 years

Study Arms (2)

Head Scans

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.

Body Scans

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients of all cancer types who undergo at least 5 daily treatments of proton therapy.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Jude Children's Research Hospital: lead

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (1)

• Becksfort 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 BACKGROUND

Related Links

• St. Jude Children's Research Hospital
• Clinical Trials Open at St. Jude

MeSH Terms

Conditions

Neoplasms

Study Officials

• Chia-ho Hua, PhD

  St. Jude Children's Research Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2019
• First Posted: October 14, 2019
• Study Start: January 28, 2020
• Primary Completion (Estimated): October 31, 2027
• Study Completion (Estimated): October 31, 2027
• Last Updated: April 29, 2026

Record last verified: 2026-04

Locations

US (1)