Dragon: Imaging Study on Halcyon 4.0 System for Patients Receiving Radiation Therapy

Sponsor

Washington University School of Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT05427214

Collaborator

Varian Medical Systems (Industry)

Enrollment

Location

Arm

20.4

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Brain Cancer Head and Neck Cancer Lung Cancer Gastric Cancer Ovarian Cancer Colon Cancer	Device: Halcyon 4.0 system	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

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

Actual Study Start Date :

Aug 19, 2022

Anticipated Primary Completion Date :

May 1, 2024

Anticipated Study Completion Date :

May 2, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Halcyon 4.0 imaging 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.	Device: Halcyon 4.0 system During each of the 2 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.

Arm

Intervention/Treatment

Experimental: Halcyon 4.0 imaging

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.

Device: Halcyon 4.0 system

During each of the 2 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.

Outcome Measures

Primary Outcome Measures

Percentage of images that are of sufficient quality for patient primary treatment plan construction [At 9 weeks]
Images evaluated by radiation oncologist for radiation therapy adequacy. Feasibility will be defined as a success rate of >80%.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Eligibility Criteria:

Scheduled to receive radiation therapy to one of the following sites:
Head and neck/brain (n=10)
Thorax (n=10)
Abdomen (n=10)
Pelvis (n=10)
At least 18 years of age
If the patient will be receiving IV contrast on study: Adequate renal function as defined by a serum creatinine < 1.4, or, for patients with chronic kidney disease, a stable serum creatinine < 2.0. Note: if no IV contrast will be administered on study, patient may enroll without creatinine level documented.
If the patient is a woman of childbearing potential, a negative pregnancy test must be obtained. Contraceptive use is not an adequate documentation of no chance of pregnancy.
Able to understand and willing to sign an IRB approved written informed consent document.