Feasibility Study of CBCT for IGRT in Cancer Patients

March 12, 2026 updated by: Varian, a Siemens Healthineers Company

A Feasibility Study of a Novel Cone-Beam CT Approach for Image Guided Radiotherapy in Cancer Patients

Cone beam computed tomography (CBCT) is an imaging technology that is incorporated into many modern radiation therapy systems. The quality of conventional CBCT is good enough to align patients for their daily radiation therapy but CBCT images have poor contrast and are susceptible to imaging artefacts that limit their usability for other tasks in the radiation therapy workflow.

Varian Medical Systems, the sponsor of this study, has developed new CBCT imaging technology called HyperSight that so far has demonstrated increased image quality compared with conventional CBCT images. This new HyperSight CBCT imager has previously been built into Varian Halcyon and Ethos treatment machines, where the imager is enclosed in a ring that rotates around the patient. Now, HyperSight has been built into a Varian treatment machine, called TrueBeam, where the imager is mounted on a C-shaped arm that rotates around you to acquire an image.

This study is being done to evaluate the image quality of HyperSight CBCT compared to conventional CBCT images, and to determine whether HyperSight CBCT can improve the process of delivering radiation treatments.

The goal of this study is to collect images from this new HyperSight-TrueBeam CBCT imager from a variety of patients and locations in the body. The images will be analyzed to determine whether their quality is high enough to use for tasks other than positioning patients for treatment. For example, the study will determine whether the HyperSight images could be used to calculate a radiation plan.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Ohio
      • Columbus, Ohio, United States, 43212
        • Recruiting
        • Stefanie Spielman Comprehensive Breast Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ashley Cetnar, PhD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ashley Cetnar, PhD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • James Outpatient Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ashley Cetnar, PhD
      • Columbus, Ohio, United States, 43210
        • Recruiting
        • Ohio State University, Brain and Spine Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Ashley Cetnar, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Patient age ≥ 18
  2. Patient is receiving radiation therapy for head and neck, thorax, liver, breast, genitourinary, or gastrointestinal malignancies
  3. A CBCT acquisition for localization is standard of care for the radiation therapy treatment plan being delivered

Exclusion Criteria:

  1. Patient has ECOG Performance Status ≥3.
  2. Patient is wheelchair bound.
  3. Patient has a life expectancy <3 months.
  4. Patient is unwilling or unable to provide informed consent to participate in the study.
  5. Patient is pregnant or has plans for pregnancy during the period of treatment.
  6. Patient is part of a vulnerable population (per ISO 14155:2020, "individuals who are unable to fully understand all aspects of the investigation that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response"). This includes prisoners.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: HyperSight Imaging Arm
Device: Comparison of HyperSight CBCT imaging to conventional CBCT imaging.
Participants will receive their daily radiation treatment on a radiation therapy system equipped with HyperSight CBCT imaging. For at least 1 and up to 3 treatment fractions, participants will receive their daily radiation treatment on a system equipped with conventional CBCT imaging.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of Image Contrast Resolution
Time Frame: End of radiation treatment at 9 weeks.
The difference in contrast resolution will be evaluated between a standard CBCT image, a CBCT image acquired using HyperSight technology, and a standard fan-beam CT acquired as part of the treatment simulation and planning process
End of radiation treatment at 9 weeks.
Comparison of Image Uniformity
Time Frame: End of radiation treatment at 9 weeks.
The difference in image uniformity will be evaluated between a standard CBCT image, a CBCT image acquired using HyperSight technology, and a standard fan-beam CT acquired as part of the treatment simulation and planning process.
End of radiation treatment at 9 weeks.
Qualitative Image Comparison
Time Frame: End of radiation treatment at 9 weeks.
Qualitative comparison of HyperSight CBCT to conventional CBCT to determine preferred imaging for patient localization for daily treatment. Clinician observers will rank their preference using a 5-point Likert scale, where 1 represents strong preference of one imaging modality and 5 represents strong preference for the other modality.
End of radiation treatment at 9 weeks.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction of Metal Artifacts
Time Frame: End of radiation treatment at 9 weeks.
In patients with a metal implant in the imaging field, the volume [cubic centimeters] of the metal artefact will be compared between a standard CBCT image, a CBCT image acquired using HyperSight technology, and a standard fan-beam CT acquired as part of the treatment simulation and planning process.
End of radiation treatment at 9 weeks.
Imaging Time for Large Treatment Volumes
Time Frame: End of radiation treatment at 9 weeks.
For participants where multiple conventional CBCTs must be acquired and stitched together to capture the entire treatment field, the time [seconds] required for the overall imaging session will be recorded and compared between HyperSight CBCT and conventional CBCT.
End of radiation treatment at 9 weeks.
Imaging Time for Breath Hold Imaging
Time Frame: End of radiation treatment at 9 weeks.
For participants who undergo breath-hold imaging, the time [seconds] required for the overall imaging session will be recorded and compared between HyperSight CBCT and conventional CBCT.
End of radiation treatment at 9 weeks.
Patient Tolerance of Breath Hold Imaging
Time Frame: End of radiation treatment at 9 weeks.
For participants who undergo breath-hold imaging, the total number of individual breath-holds required for a complete image acquisition will be recorded and compared between HyperSight CBCT and conventional CBCT.
End of radiation treatment at 9 weeks.
Feasibility of HyperSight CBCT for Treatment Planning
Time Frame: End of radiation treatment at 9 weeks.
For anatomical regions where there are limited anatomical deformations expected between image acquisitions, the radiation doses calculated for individual anatomical structures in a participant's treatment plan, which is based on their fan-beam simulation CT, will be compared to doses for the same structures after re-calculating the dose distribution for the same treatment plan using both the HyperSight CBCT and conventional standard CBCT.
End of radiation treatment at 9 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Varian, a Siemens Healthineers Company

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 19, 2025

Primary Completion (Estimated)

August 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

November 6, 2024

First Submitted That Met QC Criteria

November 6, 2024

First Posted (Actual)

November 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VAR-2023-04

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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