NCT06056063

Project Looking-Glass Evaluation

Evaluation of Novel CT Imaging for Simulation on a Linear Accelerator

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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.

Conditions

• Cone-Beam Computed Tomography

Interventions

Type	Name	Description
DEVICE	Halcyon 4.0	This Halcyon 4.0 is a new imaging hardware recently developed by Varian and approved by the FDA.

Timeline

• Start date: 2023-11-19
• Primary completion: 2024-10-11
• Completion: 2026-09-30
• First posted: 2023-09-28
• Last updated: 2025-09-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study