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

March 25, 2024 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Pamela Samson, M.D., MPHS
  • Phone Number: 314-801-3806
  • Email: psamson@wustl.edu

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University School of Medicine
        • Sub-Investigator:
          • Eric Laugeman, M.S.
        • Sub-Investigator:
          • Tianyu Zhao, Ph.D.
        • Contact:
        • Principal Investigator:
          • Pamela Samson, M.D., MPHS
        • Sub-Investigator:
          • Hua Li, Ph.D.
        • Sub-Investigator:
          • Taeho Kim, Ph.D.
        • Sub-Investigator:
          • Nels Knutson, Ph.D.
        • Sub-Investigator:
          • Hyun Kim, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Varian Medical Systems

Investigators

  • Principal Investigator: Pamela Samson, M.D., MPHS, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 19, 2022

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

October 2, 2024

Study Registration Dates

First Submitted

June 16, 2022

First Submitted That Met QC Criteria

June 16, 2022

First Posted (Actual)

June 22, 2022

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 25, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 202205118

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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