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NCT Number: NCT04125095

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 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Pediatric Cancer Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

About this study

Image guidance data collected in this study include daily volumetric pre-treatment CBCT for image guidance, post-correction CBCT, weekly post-treatment CBCT, and 2D orthogonal radiographs. Setup uncertainty will be estimated for head and body cohorts separately, further divided into different anatomic sites. The usefulness and necessity of daily volumetric image guidance for pediatric proton therapy patients will be determined. Knowledge gained from this study will provide a basis for reducing patient positioning uncertainty and designing optimal treatment plans for pediatric patients receiving proton therapy.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Site-specific distributions of patient setup uncertainty.

    Time frame: 5 years after activation

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

Secondary outcomes

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

    Time frame: 5 years

    This is to determine if setup corrections estimated from orthogonal radiographs are similar to those from volumetric imaging. The differences of each positional shift (x, y, z, pitch, roll, yaw) are measured.

  2. Residual errors after image-guided setup corrections

    Time frame: 5 years

    This is to determine if residual setup errors are submillimeter after image guidance with robotic cone beam computed tomography and 6 degree-of-freedom patient positioner. Residual errors differences for six parameters (x, y, z, pitch, roll, yaw) are measured.

  3. Distributions of intra-fractional patient motion

    Time frame: 5 years

    This is to estimate the change in patient position during a treatment fraction based on pre- and post-fractional volumetric imaging. The differences of each positional shift (x, y, z, pitch, roll, yaw) are measured.

  4. Risk factors of large setup uncertainty and intra-fractional movement

    Time frame: 5 years

    Risk factors (e.g., age, anesthesia, and anatomic site) that associate with the significantly large setup uncertainty and intra-fractional movement will be identified. The association with p value between age and setup uncertainty is measured.

  5. Risk factors of large setup uncertainty and intra-fractional movement

    Time frame: 5 years

    Risk factors (e.g., age, anesthesia, and anatomic site) that associate with the significantly large setup uncertainty and intra-fractional movement will be identified. The association with p value between anesthesia and setup uncertainty is measured.

  6. Risk factors of large setup uncertainty and intra-fractional movement

    Time frame: 5 years

    Risk factors (e.g., age, anesthesia, and anatomic site) that associate with the significantly large setup uncertainty and intra-fractional movement will be identified. The association with p value between anatomic site and setup uncertainty is measured.

Sponsors and collaborators

Lead sponsor

St. Jude Children's Research Hospital

Other

Registry information

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Oct 14, 2019
Registry last updated
Jun 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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