Imaging Study on Halcyon 4.0 System for Patients Receiving Radiation Therapy

Not Applicable

Completed

• Conditions: Colon Cancer; Brain Cancer; Ovarian Cancer; Head and Neck Cancer; Lung Cancer; Gastric Cancer
• Interventions: Device: Halcyon 4.0 system

• Registration Number: NCT05427214
• Lead Sponsor: Washington University School of Medicine

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-16
• Study First Submitted QC: 2022-06-16
• Study First Posted: 2022-06-22
• Study Start: 2022-08-19
• Status Verified: 2024-10
• Primary Completion: 2024-10-17
• Study Completion: 2024-10-17
• Last Update Submitted: 2024-10-17
• Last Update Posted: 2024-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Halcyon 4.0 imaging	Halcyon 4.0 system	Patients planning to receive radiation therapy to the head and neck/brain, thorax, abdomen, or pelvis will undergo imaging on the Halcyon 4.0 system. Patients will return for a minimum of 2 sessions over 9 weeks, with a cumulative total of 10 images being collected.

Primary Outcome Measures

Name	Time	Method
Percentage of images that are of sufficient quality for patient primary treatment plan construction	At 9 weeks	If the treatment target and surrounding organs at risk can be visualized and contoured for treatment planning purposes and a treatment plan created that meets the stated objectives ( or better than the stated objectives), then the kV CBCT images will be deemed feasible.

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States