Clinical trial NCT04125095: Estimating Setup Uncertainty in Pediatric Proton Therapy Using Volumetric Images
Official title: Estimating Setup Uncertainty in Pediatric Proton Therapy Using Volumetric Images
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Pediatric Cancer
Keywords: Proton therapy, Children and adolescents, Image guidance, Setup uncertainty
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2019-10-14
Enrollment: 367
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients of all cancer types who undergo at least 5 daily treatments of proton therapy.

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Site-specific distributions of patient setup uncertainty.
timeFrame: 5 years after activation
Secondary outcomes:
measure: Differences in setup errors calculated from orthogonal radiographs and cone beam computed tomography (CBCT)
timeFrame: 5 years
measure: Residual errors after image-guided setup corrections
timeFrame: 5 years
measure: Distributions of intra-fractional patient motion
timeFrame: 5 years
measure: Risk factors of large setup uncertainty and intra-fractional movement
timeFrame: 5 years
measure: Risk factors of large setup uncertainty and intra-fractional movement
timeFrame: 5 years
measure: Risk factors of large setup uncertainty and intra-fractional movement
timeFrame: 5 years
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Chia-ho Hua, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.