Evaluation of On-Couch CBCT Image Quality
NCT Number: NCT06576908
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Head and Neck Cancer|Thoracic Cancer|Abdominal Cancer|Pelvic Cancer
Interventions: DEVICE: HyperSight Imaging
Sponsor: Varian, a Siemens Healthineers Company
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 46
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: OTHER
Start Date: 2024-08
Completion Date: 2025-08
Locations: Princess Margaret Cancer Centre (University Health Network), Toronto, Ontario, M5G 2M9, Canada

Summary:
This is a prospective, single-arm, single-site study designed to generate data describing the image quality and applicability/useability of a high-performance, on-couch CBCT imaging technology (HyperSight) in patients receiving radiation treatment for cancer on a C-arm linear accelerator (TrueBeam).

Primary Outcome Measures: Comparison of overall free-breathing image quality: HyperSight CBCT vs Conventional CBCT, Semi-quantitative scoring (5-point Likert scale) of on-treatment, free-breathing HyperSight-TrueBeam CBCT images compared to on-treatment, free-breathing conventional TrueBeam CBCT images by three independent observers. The Likert scale values will represent a range of opinion from strong preference for HyperSight-TrueBeam CBCT images to strong preference for conventional TrueBeam CBCT images., Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).
Secondary Outcome Measures: Comparison of overall image quality: HyperSight CBCT vs Computed Tomography (CT) simulation images, Semi-quantitative scoring (5-point Likert scale) of on-treatment HyperSight-TrueBeam CBCT images compared to pre-treatment, diagnostic-quality, planning CT images by three independent observers. The Likert scale values will represent a range of opinion from strong preference for HyperSight-TrueBeam CBCT images to strong preference for planning CT images., Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).|Comparison of motion artifacts: HyperSight CBCT vs. Conventional CBCT, Semi-quantitative scoring (5-point Likert scale) of motion artifacts in HyperSight-TrueBeam CBCT images compared to on-treatment conventional TrueBeam CBCT images by three independent observers. The Likert scale values will represent a range of opinion from strong preference for HyperSight-TrueBeam CBCT images to strong preference for conventional TrueBeam CBCT images., Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).|Comparison of metal artifacts: HyperSight CBCT vs. Conventional CBCT, Semi-quantitative scoring (5-point Likert scale) of metal artifacts in HyperSight-TrueBeam CBCT images compared to on-treatment conventional TrueBeam CBCT images by three independent observers. The Likert scale values will represent a range of opinion from strong preference for HyperSight-TrueBeam CBCT images to strong preference for conventional TrueBeam CBCT images., Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).|Comparison of overall breath hold image quality: HyperSight CBCT vs Conventional CBCT, Semi-quantitative scoring (5-point Likert scale) of on-treatment, breath-hold HyperSight-TrueBeam CBCT images compared to on-treatment, breath-hold conventional TrueBeam CBCT images by three independent observers. The Likert scale values will represent a range of opinion from strong preference for HyperSight-TrueBeam CBCT images to strong preference for conventional TrueBeam CBCT images., Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).|Comparison of Hounsfield Unit accuracy: HyperSight CBCT vs Conventional CBCT and CT Simulation images, The HU accuracy of clinical HyperSight-TrueBeam CBCTs will be evaluated by comparing mean HUs and SDs for regions of interest in different tissue types (muscle, fat, lungs, and bones) on the planning CTs, HyperSight-TrueBeam CBCTs, and conventional TrueBeam CBCT., Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).|Patient's perspectives of on-treatment HyperSight-TrueBeam CBCT, Semi-structured interview integrating the validated six-item State Anxiety scale derived from the State-Tait Anxiety Inventory., Day 1 of radiation treatment and the last day of radiation treatment (up to 6 weeks after the start of treatment).|Patient tolerability of on-treatment, breath-hold HyperSight-TrueBeam CBCT imaging., Proportion of patients able to complete HyperSight-TrueBeam CBCT breath-hold imaging in a single breath-hold compared to conventional TrueBeam CBCT breath-hold imaging., Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).|Patient tolerability of on-treatment, breath-hold HyperSight-TrueBeam CBCT imaging., Number of breath-holds required to complete HyperSight-TrueBeam CBCT breath-hold imaging compared to conventional TrueBeam CBCT breath-hold imaging., Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).|Breath hold imaging time, Total HyperSight-TrueBeam CBCT breath-hold image acquisition time compared to conventional TrueBeam CBCT breath-hold imaging., Day 1 of radiation treatment, day 2 of radiation treatment, and the last day of radiation treatment (up to 6 weeks after the start of treatment).