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Estimating Setup Uncertainty in Pediatric Proton Therapy Using Volumetric Images

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ClinicalTrials.gov Identifier: NCT04125095
Recruitment Status : Not yet recruiting
First Posted : October 14, 2019
Last Update Posted : January 3, 2020
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

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.

Condition or disease
Pediatric Cancer

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.

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Estimating Setup Uncertainty in Pediatric Proton Therapy Using Volumetric Images
Estimated Study Start Date : January 2020
Estimated Primary Completion Date : October 31, 2024
Estimated Study Completion Date : October 31, 2024

Group/Cohort
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.



Primary Outcome Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric patients of all cancer types who undergo at least 5 daily treatments of proton therapy.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04125095


Contacts
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Contact: Chia-ho Hua, PhD 866-278-5833 referralinfo@stjude.org

Locations
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United States, Tennessee
St. Jude Children's Research Hospital
Memphis, Tennessee, United States, 38105
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
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Principal Investigator: Chia-ho Hua, PhD St. Jude Children's Research Hospital

Additional Information:
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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT04125095    
Other Study ID Numbers: SJPRONTON2
First Posted: October 14, 2019    Key Record Dates
Last Update Posted: January 3, 2020
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Jude Children's Research Hospital:
Proton therapy, Children and adolescents, Image guidance, Setup uncertainty