Halcyon 4.0 for Cone Beam CT

Overseen By Karen Tang

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Abramson Cancer Center at Penn Medicine

Disqualifiers: Pregnancy, Proton therapy, Others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 1 year

27 Participants Needed

Trial Summary

What is the purpose of this trial?

Pilot study to validate the new design and workflow of Cone-Beam CT imaging for radiation therapy treatment simulation.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Halcyon 4.0 for Cone Beam CT?

Research shows that the Halcyon system provides stable and high-quality imaging over time, with improved image quality metrics like signal-to-noise ratio and contrast-to-noise ratio, especially in certain protocols. Additionally, Halcyon offers similar treatment delivery accuracy and slightly better coverage for head and neck cancer patients compared to other methods, indicating its effectiveness in radiotherapy applications. ^{1 2 3 4 5}

Is the Halcyon 4.0 system safe for use in humans?

The Halcyon system, including its Cone Beam CT (CBCT) imaging, has been assessed for safety in clinical settings. Studies show that while it delivers additional radiation doses to patients, these doses are within acceptable limits and can be managed to minimize risk. The system has been used successfully for image-guided radiotherapy, indicating it is generally safe for human use. ^{1 5 6 7 8}

How is the Halcyon 4.0 treatment for Cone Beam CT different from other treatments?

Halcyon 4.0 is unique because it uses a four-dimensional cone beam CT (4D-CBCT) with adaptive gantry rotation and data sampling, which aligns with the patient's breathing cycle to maintain image quality while minimizing radiation exposure. This approach is different from traditional CT methods, offering improved temporal resolution and consistency. ^{9 10 11 12 13}

Research Team

Michelle Alonso-Basanta, MD, PhD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

This trial is for adults over 18 who are set to receive external beam radiotherapy at the Perelman Center for cancers like head-and-neck, thoracic, breast, gastrointestinal, gynecologic or genitourinary. They must understand the study and consent to it. A full treatment plan with CT images and radiation prescriptions is required.

Inclusion Criteria

I have all my radiation treatment records available.

I will receive radiotherapy at the Perelman Center for cancers like head, neck, lung, breast, stomach, reproductive organs.

I understand what participating in the study involves and can give my consent.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo standard of care radiation therapy with novel CBCT imaging for treatment simulation

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Halcyon 4.0

Trial Overview The pilot study is testing Halcyon 4.0's new design in Cone-Beam CT imaging technology used during radiation therapy treatment simulation to see how well it works and fits into clinical workflows.

Participant Groups

Group I: Evaluate the Halcyon 4.0 obtained CBCT in comparison to a CT SIM for radiotherapy dose planning Experimental Treatment 1 Intervention

To evaluate the Halcyon 4.0 as a machine that will obtain CBCT that will be comparable to a CT simulator for radiotherapy treatment planning dose calculation. The novel CBCT images of subjects with malignancies from six disease sites obtained during the course of treatment for evaluation in place of the standard evaluation CBCT will be compared to their initial standard conventional CT simulation images used for treatment planning.

Who Is Running the Clinical Trial?

Abramson Cancer Center at Penn Medicine

Lead Sponsor

Trials

425

Recruited

464,000+

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. England pubmed.ncbi.nlm.nih.gov

Long-term Inter-protocol kV CBCT image quality assessment for a ring-gantry linac via automated QA approach. [2021]

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

Two novel stereotactic radiotherapy methods for locally advanced, previously irradiated head and neck cancers patients. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Dose indices of kilovoltage cone beam computed tomography for various image guided radiotherapy protocols. [2023]

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

A combination-weighted Feldkamp-based reconstruction algorithm for cone-beam CT. [2006]

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

Clinical safety assessment of the Halcyon system. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Characterization of the Megavoltage Cone-Beam Computed Tomography (MV-CBCT) System on HalcyonTM for IGRT: Image Quality Benchmark, Clinical Performance, and Organ Doses. [2020]

7. 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]

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

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

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

Four-dimensional cone beam CT with adaptive gantry rotation and adaptive data sampling. [2022]

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

Feldkamp-type VOI reconstruction from super-short-scan cone-beam data. [2017]

11. England pubmed.ncbi.nlm.nih.gov

Evaluating the four-dimensional cone beam computed tomography with varying gantry rotation speed. [2019]

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

Cone-beam imaging in dentistry. [2022]

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

A comparison of a new limited cone beam computed tomography machine for dental use with a multidetector row helical CT machine. [2022]