Cone-Beam Computed Tomography Clinical Trial
Official title:
Evaluation of Novel CT Imaging for Simulation on a Linear Accelerator
Pilot study to validate the new design and workflow of Cone-Beam CT imaging for radiation therapy treatment simulation.
Status | Recruiting |
Enrollment | 36 |
Est. completion date | September 2024 |
Est. primary completion date | September 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Subjects will be treated with external beam radiotherapy at the Perelman Center for Advanced Medicine for any of the following malignancies: head-and-neck, thoracic, breast, gastrointestinal, gynecologic, or genitourinary. - Age = 18 years - Ability to understand the requirements of the study and to give written informed consent, as determined by the treating physician - Availability of a complete set of treatment plans, including CT simulation images, target and normal structure contours, and radiation treatment prescriptions Exclusion Criteria: - Subjects who are pregnant or have plans for pregnancy during the period of treatment. - Any malignancy not stated above. - Those unable to be treated on any linear accelerator (whether Truebeamâ„¢ or Halcyonâ„¢) unit either due to subject anatomy or treatment plan. - Those undergoing proton therapy. |
Country | Name | City | State |
---|---|---|---|
United States | Perelman Center for Advanced Medicine | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
Abramson Cancer Center at Penn Medicine | Varian Medical Systems |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 1 year | |
Primary | 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) | 1 year | |
Primary | 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 | 1 year | |
Primary | 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. | 1 year | |
Secondary | 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. | 1 year |
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