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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
Exploratory Objectives
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Site-specific distributions of patient setup uncertainty. | The numbers of subjects enrolled in the head cohort and the body cohort. | 5 years after activation |
| Measure | Description | Time Frame |
|---|---|---|
| Differences in setup errors calculated from orthogonal radiographs and cone beam computed tomography (CBCT) | 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. | 5 years |
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Inclusion Criteria:
Exclusion Criteria:
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Pediatric patients of all cancer types who undergo at least 5 daily treatments of proton therapy.
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| Name | Affiliation | Role |
|---|---|---|
| Chia-ho Hua, PhD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38001746 | Background | 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. |
| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Sep 14, 2021 | Nov 22, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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| Residual errors after image-guided setup corrections |
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. |
| 5 years |
| Distributions of intra-fractional patient motion | 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. | 5 years |
| Risk factors of large setup uncertainty and intra-fractional movement | 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 years |
| Risk factors of large setup uncertainty and intra-fractional movement | 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. | 5 years |
| Risk factors of large setup uncertainty and intra-fractional movement | 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. | 5 years |
| Clinical Trials Open at St. Jude | View source |