Imaging Study on Halcyon 4.0 System for Patients Receiving Radiation Therapy

Study Overview
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Brief Summary
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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.

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

Conditions
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Brain Cancer, Head and Neck Cancer, Lung Cancer, Gastric Cancer, Ovarian Cancer, Colon Cancer

Intervention / Treatment
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* Device: Halcyon 4.0 system


Participation Criteria
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Eligibility Criteria
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Eligibility Criteria: Planning 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Halcyon 4.0 imaging<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of images that are of sufficient quality for patient primary treatment plan construction | 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. | At 9 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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radiation therapy, halcyon, brain radiation, thoracic radiation, abdominal radiation, pelvic radiation