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Clinical Trials in the USA / NCT06681233
Recruiting Not applicable

Feasibility Study of CBCT for IGRT in Cancer Patients

NCT06681233 · tracked via the Priya Life Science USA tracker
Sponsor
Varian, a Siemens Healthineers Company
Phase
Not applicable
Started
2025-02-19
Last updated
2026-03-13

Condition(s) studied

Head and Neck CancersBreast CancerThoracic CancersLiver CancerGenito Urinary CancerGastrointestinal Cancers

Investigational drug(s) / intervention(s)

Comparison of HyperSight CBCT imaging to conventional CBCT imaging.

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Comparison of Image Contrast Resolution — 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 — 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 — 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.

Trial sites (4)

FacilityCityRegionStatus
James Outpatient Center Columbus Ohio Recruiting
Ohio State University, Brain and Spine Hospital Columbus Ohio Recruiting
The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute Columbus Ohio Recruiting
Stefanie Spielman Comprehensive Breast Center Columbus Ohio Recruiting

More Varian, a Siemens Healthineers Company trials in the USA

FLASH Radiotherapy for the Treatment of Symptomatic Bone Metastases in the Thorax Active, not recruiting
Evaluation of Improved Onboard Patient Imaging Active, not recruiting
Daily Adaptive Radiation Therapy Using an Individualized Approach for Prostate Cancer Recruiting
A Study Evaluating a New Radiation Treatment Workflow (NGDS) Recruiting
Stereotactic Adaptive Radiation Therapy of Borderline Resectable Pancreatic Cancer an Individualized Approach Recruiting

Other trials for the same condition

Trastuzumab Deruxtecan (T-DXd) in Patients Who Have Hormone Receptor-negative and Hormone Receptor-positive HER2-low or HER2 IHC 0 Metastatic Breast Cancer Recruiting
Study to Assess the Efficacy and Safety of Rina-S in Participants With Advanced Gastrointestinal (GI) Cancers Recruiting
An Investigational Study of BG-75202 Alone and in Combination With Other Therapeutic Agents in Adults With Advanced Solid Tumors Recruiting
Study of Patritumab Deruxtecan With Other Anticancer Agents in Participants With HER2 Positive Breast Cancer That Has Spread and Cannot Be Surgically Removed (MK-1022-009) Recruiting
Evaluation of Improved Onboard Patient Imaging Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06681233 on ClinicalTrials.gov ↗ ← All trials in the USA