52 Participants Needed

Halcyon 4.0 Imaging System for Cancer Radiation Planning

(Dragon Trial)

Pamela Samson, M.D., MPHS profile photo
Overseen ByPamela Samson, M.D., MPHS
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Washington University School of Medicine
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a new radiotherapy system called Halcyon 4.0 to see if it can quickly and safely capture images needed for planning cancer treatments. The goal is to improve the speed and safety of radiation therapy planning for cancer patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your doctor.

Is the Halcyon 4.0 Imaging System safe for use in humans?

The Halcyon system has been assessed for clinical safety and is considered safe for use in humans, with treatment plans recognized as clinically acceptable and efficient. However, daily imaging with the system can increase radiation exposure, which may affect the risk of secondary cancer.12345

How does the Halcyon 4.0 Imaging System for Cancer Radiation Planning differ from other treatments?

The Halcyon 4.0 system is unique because it offers fast and efficient delivery of radiation therapy with improved sparing of healthy organs, using a single-energy, flattening-filter-free beam and an enclosed bore design. It simplifies the treatment process with automatic imaging and alignment, making it suitable for clinics with limited resources.12456

What data supports the effectiveness of the Halcyon 4.0 system for cancer radiation planning?

Research shows that the Halcyon system provides fast and efficient radiation treatment with good accuracy, especially for breast and cervical cancer. It reduces radiation exposure to nearby organs and shortens treatment time compared to other systems, making it a promising option for cancer radiation therapy.12678

Who Is on the Research Team?

PS

Pamela Samson, M.D., MPHS

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for adults over 18 who are set to receive radiation therapy for certain cancers (brain, head and neck, lung, stomach, colon) and can consent to the study. Women must not be pregnant. If IV contrast is used in the study, participants need normal or stable kidney function.

Inclusion Criteria

I am planning to undergo radiation therapy on my head, neck, chest, abdomen, or pelvis.
My kidney function is good enough for IV contrast, with creatinine below 1.4 or stable below 2.0 if I have chronic kidney disease.
I am a woman who can have children and I have a negative pregnancy test.
See 1 more

Exclusion Criteria

Not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Patients undergo imaging on the Halcyon 4.0 system to evaluate image quality for radiation treatment planning

9 weeks
Minimum of 2 sessions

Follow-up

Participants are monitored for safety and effectiveness after imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Halcyon 4.0 system
Trial Overview The Halcyon 4.0 system's ability to create quality images for radiation treatment planning is being tested. This new technology aims to reduce image acquisition time and patient exposure to radiation during scans.
How Is the Trial Designed?
1Treatment groups
Experimental Treatment
Group I: Halcyon 4.0 imagingExperimental Treatment1 Intervention
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.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials
2,027
Recruited
2,353,000+

Varian Medical Systems

Industry Sponsor

Trials
63
Recruited
3,700+

Dow R. Wilson

Varian Medical Systems

Chief Executive Officer since 2012

MBA from Dartmouth's Amos Tuck School of Business, BA from Brigham Young University

Dr. Deepak Khuntia

Varian Medical Systems

Chief Medical Officer since 2020

MD from the University of Cambridge, PhD from the University of Leicester

Published Research Related to This Trial

Using specific kV-CBCT protocols can significantly reduce imaging doses to normal tissues during radiotherapy, with reductions of up to 50% observed in certain protocols like Fast and Low Dose modes for Pelvis and Head imaging.
The study highlights the importance of selecting appropriate imaging protocols to minimize radiation exposure, which can help lower the risk of secondary cancers while still maintaining adequate image quality for treatment planning.
Imaging doses for different CBCT protocols on the Halcyon 3.0 linear accelerator - TLD measurements in an anthropomorphic phantom.Altergot, A., Schürmann, M., Jungert, T., et al.[2023]

Citations

Clinical safety assessment of the Halcyon system. [2020]
Dosimetric and radiobiological comparison between conventional and hypofractionated breast treatment plans using the Halcyon system. [2023]
Plan quality comparison for cervical carcinoma treated with Halcyon and Trilogy intensity-modulated radiotherapy. [2023]
Treatment planning comparison of volumetric modulated arc therapy with the trilogy and the Halcyon for bilateral breast cancer. [2021]
Field-in-field breast planning for a jawless, double-stack MLC LINAC using flattening-filter-free beams. [2023]
Imaging doses for different CBCT protocols on the Halcyon 3.0 linear accelerator - TLD measurements in an anthropomorphic phantom. [2023]
TG-51 reference dosimetry for the Halcyon™: A clinical experience. [2019]
Evaluating the sensitivity of Halcyon's automatic transit image acquisition for treatment error detection: A phantom study using static IMRT. [2020]
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