Pilot study to validate the new design and workflow of Cone-Beam CT imaging for radiation therapy treatment simulation.
This study is a prospective, non-randomized imaging evaluation study. A cohort of subjects undergoing standard of care radiation therapy will be selected based on malignancies from six disease sites. The Halcyon 4.0 images acquired in place of standard evaluation CT scans during the course of treatment will be used for target volume delineation and normal structures segmentation. Treatment plans will be recalculated based on the Halcyon 4.0 images from this system and compared to the original treatment plan. Dose differences will be evaluated. Two-tailed t-test will be used to compare the statistical significance of the dosimetric results as well as the volumetric differences among target volume and the volumes of organs at risk.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
OTHER
Masking
NONE
Enrollment
27
This Halcyon 4.0 is a new imaging hardware recently developed by Varian and approved by the FDA.
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Acceptability of image quality of the novel cone-beam CT imaging system compared to that of standard cone-beam CT imaging and that of conventional fan beam CT imaging used for radiotherapy planning purposes
Qualitative results (Yes is acceptable/No is not acceptable) will be reported as tabulated data to demonstrate the differences from the standard practice
Time frame: 1 year
Ease of use of the novel cone-beam CT imaging system compared to standard practice
Ease of use of the novel cone-beam CT imaging system on a scale of 1 (very easy to use, no difficulty) to 5 (unable to use due to difficulty)
Time frame: 1 year
Quantitative comparison of the image quality of the novel cone-beam CT imaging system to that of standard cone-beam CT imaging and that of conventional fan beam CT imaging used for radiotherapy planning purposes
A scale of Better/Worse/Equal will be used for metrics such as CBCT image artifact, CBCT image quality for OAR contouring, CBCT image quality for GTV contouring, motion artifacts, auto-segmentation ability, electron density similarity
Time frame: 1 year
Statistical significance of quantitative comparison of the image quality of the novel cone-beam CT imaging system and standard practice
For situations that the quantitative results will be measured, such as the structure volume or predicted electron densities etc., statistical significance will be calculated.
Time frame: 1 year
Evaluation of the suitability and workflow of the novel CBCT images for radiation treatment planning and dose calculation.
The secondary endpoint is to compare the accuracies of dose and volume calculations to the standard arm using the conventional CT simulation.
Time frame: 1 year
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