Halcyon 4.0 Imaging System for Cancer Radiation Planning

(Dragon Trial)

Overseen By Pamela Samson, M.D., MPHS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Pregnancy, Inadequate renal function, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

52 Participants Needed

Trial Summary

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.

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. ^{1 2 3 4 5}

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. ^{1 3 6 7 8}

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. ^{1 3 5 7 8}

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.

Research Team

Pamela Samson, M.D., MPHS

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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.

Exclusion Criteria

Not applicable.

Timeline

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

Treatment Details

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.

Participant Groups

Group I: Halcyon 4.0 imaging Experimental Treatment 1 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.

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

Findings from Research

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Clinical safety assessment of the Halcyon system. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Dosimetric and radiobiological comparison between conventional and hypofractionated breast treatment plans using the Halcyon system. [2023]

3. Australia pubmed.ncbi.nlm.nih.gov

Plan quality comparison for cervical carcinoma treated with Halcyon and Trilogy intensity-modulated radiotherapy. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Treatment planning comparison of volumetric modulated arc therapy with the trilogy and the Halcyon for bilateral breast cancer. [2021]

5. United States pubmed.ncbi.nlm.nih.gov

Field-in-field breast planning for a jawless, double-stack MLC LINAC using flattening-filter-free beams. [2023]

6. Germany pubmed.ncbi.nlm.nih.gov

Imaging doses for different CBCT protocols on the Halcyon 3.0 linear accelerator - TLD measurements in an anthropomorphic phantom. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

TG-51 reference dosimetry for the Halcyon™: A clinical experience. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluating the sensitivity of Halcyon's automatic transit image acquisition for treatment error detection: A phantom study using static IMRT. [2020]