Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, 19104, United States
NCT Number: NCT06056063
Pilot study to validate the new design and workflow of Cone-Beam CT imaging for radiation therapy treatment simulation.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Interventional
Not applicable
Philadelphia, Pennsylvania, 19104, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
This Halcyon 4.0 is a new imaging hardware recently developed by Varian and approved by the FDA.
Time frame: 1 year
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 on a scale of 1 (very easy to use, no difficulty) to 5 (unable to use due to difficulty)
Time frame: 1 year
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
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
The secondary endpoint is to compare the accuracies of dose and volume calculations to the standard arm using the conventional CT simulation.
Abramson Cancer Center at Penn Medicine
Other
Evaluation of Novel CT Imaging for Simulation on a Linear Accelerator
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07726121
Artery, Cone-Beam Computed Tomography
Kielce, Poland
View Trial DetailsNCT07513792
Cone-Beam Computed Tomography, Gingival Diseases
Liège, Liege, Belgium
View Trial DetailsNCT06420713
Atrophic Maxilla, Bone Diseases
Ribeirão Preto, São Paulo, Brazil
View Trial DetailsNCT06323993
Cone-Beam Computed Tomography, DENTAL IMPLANTATION
Hangzhou, Zhejiang, China
View Trial Details