What is the mechanism of action of this treatment?

Radiotherapy, a common treatment for lung cancer, uses high-energy radiation to damage the DNA of cancer cells, preventing them from replicating and causing cell death. This precision is crucial for lung cancer patients as it targets tumors while sparing healthy tissue. Advances like the Halcyon 4.0 Radiotherapy System, which offers improved imaging and reduced radiation exposure, enhance treatment accuracy and safety, potentially improving patient outcomes and reducing side effects.

What side effects are associated with this type of intervention?

Common treatments for lung cancer, such as radiotherapy and chemoradiotherapy, can lead to side effects including pneumonitis, esophagitis, and hematological toxicities like leukopenia, neutropenia, and thrombocytopenia. Targeted therapies may cause rash, diarrhea, and liver toxicity, while immunotherapies can result in immune-related adverse events such as pneumonitis, colitis, and endocrinopathies. The Halcyon 4.0 Radiotherapy System aims to reduce radiation exposure, potentially mitigating some of these side effects.

What prior FDA approvals exist?

The FDA has approved several therapies for lung cancer, including targeted drugs and immunotherapies. For instance, pembrolizumab and cemiplimab, both checkpoint inhibitors, have shown improved survival rates when combined with chemotherapy for advanced non-small cell lung cancer (NSCLC). Additionally, durvalumab has been approved for unresectable stage III NSCLC following chemoradiotherapy. These treatments aim to enhance the efficacy of traditional therapies while managing toxicity. The Halcyon 4.0 Radiotherapy System, although not yet clinically validated, represents an advancement in radiotherapy planning by potentially reducing radiation exposure and improving image quality.

What other types of research exist?

Promising alternatives to the Halcyon 4.0 Radiotherapy System for lung cancer patients include: 1) Proton Therapy, which offers precise tumor targeting with minimal damage to surrounding tissues; 2) Magnetic Resonance Imaging-Guided Radiotherapy (MRIgRT), which provides real-time imaging for accurate treatment delivery; and 3) Stereotactic Body Radiation Therapy (SBRT) using advanced linear accelerators like TrueBeam, which allows for high-dose radiation delivery with reduced treatment times and improved patient compliance.

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Radiation Therapy

Halcyon 4.0 Imaging System for Cancer Radiation Planning (Dragon Trial)

N/A

Waitlist Available

Led By Pamela Samson, M.D., MPHS

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Planning to receive radiation therapy to head and neck/brain, thorax, abdomen, or pelvis

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 9 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Since this trial focuses on imaging rather than a drug or therapeutic intervention, side effects are related mainly to potential discomfort from lying still during imaging or reactions if IV contrast is used.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am planning to undergo radiation therapy on my head, neck, chest, abdomen, or pelvis.

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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.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 9 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 9 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 9 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Percentage of images that are of sufficient quality for patient primary treatment plan construction

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Halcyon 4.0 system

2022

N/A

~60

0 / 3Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Radiotherapy, a common treatment for lung cancer, uses high-energy radiation to damage the DNA of cancer cells, preventing them from replicating and causing cell death. This precision is crucial for lung cancer patients as it targets tumors while sparing healthy tissue. Advances like the Halcyon 4.0 Radiotherapy System, which offers improved imaging and reduced radiation exposure, enhance treatment accuracy and safety, potentially improving patient outcomes and reducing side effects.

A Review of Recent Advances in the Treatment of Elderly and Poor Performance NSCLC.The management of non-small-cell lung cancer: a case history.