NCT06681233 Feasibility Study of CBCT for IGRT in Cancer Patients
| NCT ID | NCT06681233 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Varian, a Siemens Healthineers Company |
| Condition | Head and Neck Cancers |
| Study Type | INTERVENTIONAL |
| Enrollment | 50 participants |
| Start Date | 2025-02-19 |
| Primary Completion | 2026-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 50 participants in total. It began in 2025-02-19 with a primary completion date of 2026-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06681233 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Head and Neck Cancers. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06681233 currently recruiting?
Yes, NCT06681233 is actively recruiting participants. Contact the research team at sean.davidson@varian.com for enrollment information.
Where is the NCT06681233 trial being conducted?
This trial is being conducted at Columbus, United States, Columbus, United States, Columbus, United States, Columbus, United States.
Who is sponsoring the NCT06681233 clinical trial?
NCT06681233 is sponsored by Varian, a Siemens Healthineers Company. The trial plans to enroll 50 participants.
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