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CompletedNot applicableNCT05427214
Official study title

Imaging Study on Halcyon 4.0 System for Patients Receiving Radiation Therapy

Study 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.

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Key things to know

Main goalDevice Feasibility

This describes the study’s primary purpose.

What is being studiedHalcyon 4.0 system

The study team can explain what participation involves.

Who it may be forBrain Cancer · Head and Neck Cancer

These are broad labels—not an eligibility decision.

Checked against the public recordLast updated Oct 21, 2024 · Source: ClinicalTrials.gov

Is enrollment open?Completed

Ask the study team to confirm whether enrollment is open.

What kind of study?Not applicable

Interventional

Where is it offered?1 U.S. location

Locations may change over time.

Who runs it?Washington University School of Medicine

Study sponsor

01
Study overview

What this study is about

Purpose
Device Feasibility
Study type
Interventional
Phase
Not applicable
Sponsor
Washington University School of Medicine
Interventions being studied
Device: Halcyon 4.0 system
02
Explore related studies

How this study is categorized

These labels come from structured fields and exact terms in the public record.

Treatment approach
Radiation therapy→
03
Public criteria

Who may be able to participate

The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.

Requirements people may need to meetInclusion criteria
  • 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.

Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.

04
Study sites

U.S. locations

  • Washington University School of MedicineSt Louis, Missouri

Source and freshness
Processed from ClinicalTrials.gov. Last public update: Oct 21, 2024. Always confirm current availability with the study team.

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