Estimating Setup Uncertainty in Pediatric Proton Therapy Using Volumetric Images

St. Jude Children's Research Hospital

Status: Active, not recruiting

Conditions: Pediatric Cancer

Study type: Observational

Funder types: Other

Identifiers

NCT04125095

SJPROTON2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 367 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

367 participants in 2 patient groups

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.

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.