Project Looking-Glass Evaluation

Cone-Beam Computed Tomography Clinical Trial

Official title:

Evaluation of Novel CT Imaging for Simulation on a Linear Accelerator

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06056063
• Other study ID #: UPCC 02923
• Secondary ID: 852966
• Status: Recruiting
• Phase: N/A
• Start date: November 19, 2023
• Est. completion date: September 2024

Study information

• Verified date: January 2024
• Source: Abramson Cancer Center at Penn Medicine
• Contact: Wei Xu
• Phone: 215-662-6083
• Email: weixu[@]pennmedicine.upenn.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pilot study to validate the new design and workflow of Cone-Beam CT imaging for radiation therapy treatment simulation.

Description:

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.

Recruitment information / eligibility

• 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 Truebeam™ or Halcyon™) unit either due to subject anatomy or treatment plan.

• Those undergoing proton therapy.

Related Conditions & MeSH terms

• Cone-Beam Computed Tomography

Intervention

Device:
• Halcyon 4.0
This Halcyon 4.0 is a new imaging hardware recently developed by Varian and approved by the FDA.

Locations

Country	Name	City	State
United States	Perelman Center for Advanced Medicine	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Abramson Cancer Center at Penn Medicine	Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

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