Head and Neck CancersNCT06681233
Feasibility Study of CBCT for IGRT in Cancer Patients
A study testing Comparison of HyperSight CBCT imaging to conventional CBCT imaging. in people with Head and Neck Cancers and Breast Cancer, run by Varian, a Siemens Healthineers Company at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancers, Breast Cancer, Thoracic Cancers
- What is being tested?
- Comparison of HyperSight CBCT imaging to conventional CBCT imaging.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 4 sitesUnited States
- Study dates
- 19 Feb 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age ≥ 18
- Patient is receiving radiation therapy for head and neck, thorax, liver, breast, genitourinary, or gastrointestinal malignancies
- A CBCT acquisition for localization is standard of care for the radiation therapy treatment plan being delivered
Who cannot join
- Patient has ECOG Performance Status ≥3.
- Patient is wheelchair bound.
- Patient has a life expectancy <3 months.
- Patient is unwilling or unable to provide informed consent to participate in the study.
- Patient is pregnant or has plans for pregnancy during the period of treatment.
- 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.
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States4 sites, 4 recruiting
- Recruiting
James Outpatient Center
Columbus, Ohio, 43210
Ashley Cetnar, PhD, 614-685-5233, Ashley.Cetnar@osumc.edu
Nilendu Gupta, PhD, 614-293-4204, gupta.6@osu.edu
- Recruiting
Ohio State University, Brain and Spine Hospital
Columbus, Ohio, 43210
Ashley Cetnar, PhD, 614-685-5233, Ashley.Cetnar@osumc.edu
Nilendu Gupta, PhD, 614-293-4204, gupta.6@osu.edu
- Recruiting
The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute
Columbus, Ohio, 43210
Ashley Cetnar, PhD, 614-685-5233, Ashley.Cetnar@osumc.edu
Nilendu Gupta, PhD, 614-293-4204, gupta.6@osu.edu
- Recruiting
Stefanie Spielman Comprehensive Breast Center
Columbus, Ohio, 43212
Ashley Cetnar, PhD, 614-685-5233, Ashley.Cetnar@osumc.edu
Nilendu Gupta, PhD, 614-293-4204, gupta.6@osu.edu
About this study
Official title: 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.
Read more
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.
- Conditions
- Head and Neck Cancers, Breast Cancer, Thoracic Cancers, Liver Cancer, Genito Urinary Cancer, Gastrointestinal Cancers
- Being tested
- Comparison of HyperSight CBCT imaging to conventional CBCT imaging.
- Medical subject headings
- Head and Neck Neoplasms, Breast Neoplasms, Liver Neoplasms, Urogenital Neoplasms, Gastrointestinal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of HyperSight CBCT imaging to conventional CBCT imaging.Device
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.
| Study group | Role | What they receive |
|---|---|---|
| HyperSight Imaging Arm | Experimental | Not described Receives: Device: Comparison of HyperSight CBCT imaging to conventional CBCT imaging. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Image Contrast Resolution
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
Measured: End of radiation treatment at 9 weeks.
Comparison of Image Uniformity
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.
Measured: End of radiation treatment at 9 weeks.
Qualitative Image Comparison
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.
Measured: End of radiation treatment at 9 weeks.
Secondary outcomes (5)
Reduction of Metal Artifacts
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.
Measured: End of radiation treatment at 9 weeks.
Imaging Time for Large Treatment Volumes
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.
Measured: End of radiation treatment at 9 weeks.
Imaging Time for Breath Hold Imaging
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.
Measured: End of radiation treatment at 9 weeks.
Patient Tolerance of Breath Hold Imaging
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.
Measured: End of radiation treatment at 9 weeks.
Feasibility of HyperSight CBCT for Treatment Planning
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.
Measured: End of radiation treatment at 9 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start19 Feb 2025
- Primary completionAug 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancersStudies of the same condition, open and under way.
- More trials run by Varian, a Siemens Healthineers CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a prospective, single-arm, single-site feasibility study designed to generate data evaluating the quality and applicability of the HyperSight on-couch high-performance CBCT imaging technology.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Varian, a Siemens Healthineers Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681233
- Sponsor's protocol ID
- VAR-2023-04
- Status last verified
- Mar 2026
- First submitted
- 6 Nov 2024
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of a Novel Cone-Beam CT Approach for Image Guided Radiotherapy in Cancer Patients
- ClinicalTrials.gov ID
- NCT06681233
- Acronym / sponsor ID
- VAR-2023-04
- Conditions
- Head and Neck Cancers, Breast Cancer, Thoracic Cancers, Liver Cancer, Genito Urinary Cancer, Gastrointestinal Cancers
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Varian, a Siemens Healthineers CompanyIndustry (pharma, biotech, devices)
- Study start
- 19 Feb 2025 (actual)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a prospective, single-arm, single-site feasibility study designed to generate data evaluating the quality and applicability of the HyperSight on-couch high-performance CBCT imaging technology.
| Arm | Type | Receives |
|---|---|---|
| HyperSight Imaging Arm | Experimental | Device: Comparison of HyperSight CBCT imaging to conventional CBCT imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient age ≥ 18
- Patient is receiving radiation therapy for head and neck, thorax, liver, breast, genitourinary, or gastrointestinal malignancies
- A CBCT acquisition for localization is standard of care for the radiation therapy treatment plan being delivered
Key exclusion criteria (6 listed)
- Patient has ECOG Performance Status ≥3.
- Patient is wheelchair bound.
- Patient has a life expectancy <3 months.
- Patient is unwilling or unable to provide informed consent to participate in the study.
- Patient is pregnant or has plans for pregnancy during the period of treatment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | HyperSight Imaging Arm |
Primary outcome
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
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.
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.
5 secondary outcomes
Reduction of Metal Artifacts
Time frame: End of radiation treatment at 9 weeks.
Imaging Time for Large Treatment Volumes
Time frame: End of radiation treatment at 9 weeks.
Imaging Time for Breath Hold Imaging
Time frame: End of radiation treatment at 9 weeks.
Patient Tolerance of Breath Hold Imaging
Time frame: End of radiation treatment at 9 weeks.
Feasibility of HyperSight CBCT for Treatment Planning
Time frame: End of radiation treatment at 9 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of HyperSight CBCT imaging to conventional CBCT imaging. in people with Head and Neck Cancers and Breast Cancer, run by Varian, a Siemens Healthineers Company at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sean Davidson (437-991-8294, sean.davidson@varian.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of Image Contrast Resolution (time frame: End of radiation treatment at 9 weeks.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2026.