Recruiting

HyperSight CBCT

Sponsor:

Varian, a Siemens Healthineers Company

Code:

NCT06681233

Conditions

Head and Neck Cancers

Breast Cancer

Thoracic Cancers

Liver Cancer

Genito Urinary Cancer

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Comparison of HyperSight CBCT imaging to conventional CBCT imaging.

Study Details

Brief 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 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.

Conditions

Head and Neck Cancers

Breast Cancer

Thoracic Cancers

Liver Cancer

Genito Urinary Cancer

Study ID

NCT06681233

Start date

Feb 19, 2025

Status verified date

Mar, 2026

Completion date

Sep, 2026

Anticipated

Primary completion date

Aug, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: HyperSight Imaging Arm

Interventions

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.

Primary outcome measure

  • Comparison of Image Contrast Resolution [ Time Frame: End of radiation treatment at 9 weeks. ]
  • Comparison of Image Uniformity [ Time Frame: End of radiation treatment at 9 weeks. ]
  • Qualitative Image Comparison [ Time Frame: End of radiation treatment at 9 weeks. ]

Central Contacts and Locations

Central contacts

Locations

James Outpatient Center

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Ashley Cetnar, PhD

Ohio State University, Brain and Spine Hospital

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Ashley Cetnar, PhD

The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute

Recruiting

Columbus, Ohio, United States, 43210

Contacts

Principal Investigator:

Ashley Cetnar, PhD

Stefanie Spielman Comprehensive Breast Center

Recruiting

Columbus, Ohio, United States, 43212

Contacts

Principal Investigator:

Ashley Cetnar, PhD

More Information

Sponsor

Varian, a Siemens Healthineers Company

Last update posted

Mar 13, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Varian, a Siemens Healthineers Company on 2026-03-13.