Imaging Study on 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.

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Key information

Conditions

Brain Cancer Adnexal Diseases Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Gastric Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Head and Neck Cancer Head and Neck Neoplasms Intestinal Diseases Intestinal Neoplasms Lung Cancer Lung Diseases Lung Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Respiratory Tract Diseases Respiratory Tract Neoplasms Stomach Diseases Stomach Neoplasms Thoracic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Halcyon 4.0 system

Device

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.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Collaborators

Varian Medical Systems

Registry information

Official study title

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

Acronym: Dragon

Important dates

Study start: 2022
Primary completion: 2024
Study completion: 2024
First posted: Jun 22, 2022
Registry last updated: Oct 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed