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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HyperSight Imaging arm | Experimental | Subjects have both HyperSight and conventional CBCT imaging. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HyperSight Imaging | Device | Subjects receive both HyperSight imaging and conventional imaging, on their first day of radiation treatment, on their second day of treatment, and on their last day of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Princess Margaret Cancer Centre (University Health Network) | Toronto | Ontario | M5G 2M9 | Canada |
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| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| D010386 | Pelvic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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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 in patients receiving radiation treatment for cancer.
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| 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). |