NCT05427214

Imaging Study on Halcyon 4.0 System for Patients Receiving Radiation Therapy

A Prospective Imaging Study of Target Definition and Simulation-free Planning Workflows on the Halcyon 4.0 System for Patients Receiving Radiation Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Washington University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This prospective imaging study is evaluating the feasibility of using the Halcyon 4.0 radiotherapy system for radiation therapy planning in patients with cancer. The Halcyon 4.0 system has been engineered to decrease the image acquisition time and the radiation exposure, but the system has not yet been clinically validated for use in radiation planning. This pilot study will evaluate images obtained on the Halcyon 4.0 system to assess if the quality is sufficient for radiation treatment plan construction.

Conditions

• Brain Cancer
• Head and Neck Cancer
• Lung Cancer
• Gastric Cancer
• Ovarian Cancer
• Colon Cancer

Interventions

Type	Name	Description
DEVICE	Halcyon 4.0 system	During each of the 1 or more imaging sessions, no more than 6 images total will be acquired. Only 5 images total across all of the imaging sessions will be used toward the study endpoint.

Timeline

• Start date: 2022-08-19
• Primary completion: 2024-10-17
• Completion: 2024-10-17
• First posted: 2022-06-22
• Last updated: 2024-10-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study