Halcyon 4.0 Imaging System for Cancer Radiation Planning

(Dragon Trial)

No longer recruiting at 1 trial location

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates whether a new imaging system, Halcyon 4.0, can improve radiation therapy planning for cancer patients. The goal is to determine if this system can quickly capture high-quality images with reduced radiation exposure. It targets individuals planning to receive radiation therapy for cancer in the head, neck, brain, chest, abdomen, or pelvis. Those in these situations may be suitable candidates for the study. As an unphased trial, it offers a unique opportunity to contribute to innovative imaging techniques that could enhance cancer treatment planning.

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 prior data suggests that the Halcyon 4.0 system is safe for radiation therapy planning?

Research has shown that the Halcyon 4.0 system is safe for people. Tests have confirmed its safety, and the treatment plans it creates meet medical standards. This indicates that the system is generally well-tolerated. The Halcyon 4.0 speeds up image capturing and reduces radiation exposure, enhancing patient safety. While its use in planning radiation treatments is still under study, its safety for imaging has been confirmed. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Halcyon 4.0 imaging system because it offers a cutting-edge approach to planning radiation therapy for cancer patients. Unlike standard imaging methods, the Halcyon 4.0 system provides enhanced precision and speed, which can lead to more accurate targeting of tumors while sparing healthy tissue. This system is particularly beneficial for complex areas like the head, neck, and abdomen. By improving imaging quality, it has the potential to optimize treatment outcomes and reduce side effects, making it a promising advancement in cancer care.

What evidence suggests that the Halcyon 4.0 system is effective for cancer radiation planning?

Research has shown that the Halcyon 4.0 system quickly and safely captures high-quality images for planning cancer radiation treatment. This system uses a linear accelerator, which delivers radiation to treat cancer, enhancing treatment accuracy. Studies suggest that Halcyon 4.0 reduces the time needed to capture images, making radiation planning more efficient. Additionally, the system lowers radiation exposure during imaging, potentially increasing patient safety. In this trial, participants will undergo imaging on the Halcyon 4.0 system to evaluate its effectiveness in planning radiation therapy. Although Halcyon 4.0 has not yet been fully tested for this use, these features suggest it could effectively plan radiation therapy. ^{1 2 4 5 6}

Who Is on the Research Team?

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.

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?

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

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.

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05427214

Imaging Study on Halcyon 4.0 System for Patients ... 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.

2. trials.braintumor.org trials.braintumor.org/trials/NCT05427214

Imaging Study on Halcyon 4.0 System for Patients Receiving ... 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.

3. withpower.com withpower.com/trial/phase-head-and-neck-cancer-7-2022-5080d

Halcyon 4.0 Imaging System for Cancer Radiation ... 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.

4. oncologyradiotherapy.com oncologyradiotherapy.com/articles/halcyon-unveiled-commissioning-the-future-of-cancer-care-at-the-international-center-of-oncology-benguerir-ciob-1102767.html

Halcyon Unveiled: Commissioning the Future of Cancer ... Equipment: HalcyonTM 4.0 is a fixed 6 MV-FFF beam linear accelerator that is encased in a carbon fiber bore and positioned in a ring shape ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9372831/

Clinical performance evaluation of O-Ring Halcyon Linac The Halcyon system theoretically improves the quality of radiotherapy planning, improves the positioning accuracy, shortens the treatment time, and has ...

6. varian.com varian.com/products/radiotherapy/treatment-delivery/halcyon

Halcyon Halcyon was built to maximize efficiency and treat more effectively. Its compact footprint, rapid installation, and streamlined workflows enable clinics to ...