Feasibility Study of CBCT for IGRT in Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Comparison of HyperSight CBCT imaging to conventional CBCT imaging..
- Who it may be relevant to
- Registry conditions: Head and Neck Cancers, Breast Cancer, Thoracic Cancers, Liver Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Feasibility Study of a Novel Cone-Beam CT Approach for Image Guided Radiotherapy in Cancer Patients
Overview
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.
Interventions
- 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.
Primary outcome measures
- 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.]
Secondary outcome measures (5)
- 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.]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Other
Study locations
United States · 4 centers
- James Outpatient Center — Columbus
- Ohio State University, Brain and Spine Hospital — Columbus
- The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute — Columbus
- Stefanie Spielman Comprehensive Breast Center — Columbus
Identifiers
NCT: NCT06681233 · VAR-2023-04