Imaging Study on Halcyon 4.0 System for Patients Receiving Radiation Therapy

Lung Cancer Clinical Trial

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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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05427214
• Other study ID #: 202205118
• Status: Recruiting
• Phase: N/A
• Start date: August 19, 2022
• Est. completion date: October 2, 2024

Study information

• Verified date: March 2024
• Source: Washington University School of Medicine
• Contact: Pamela Samson, M.D., MPHS
• Phone: 314-801-3806
• Email: psamson[@]wustl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: October 2, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (2)

Lead Sponsor	Collaborator
Washington University School of Medicine	Varian Medical Systems

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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

External Links

•   Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine