About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Single group
Treatments tested in this trial
Comparison of HyperSight CBCT imaging to conventional CBCT imaging.
DeviceParticipants 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.
Treatment groups
Trial outcomes
Primary outcomes
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
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.
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.
Secondary outcomes
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.
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.
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.
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.
Sponsors and contacts
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