Evaluation of On-Couch CBCT Image Quality

Evaluation of Image Quality From an On-Couch, Cone Beam Computed Tomography (CBCT) Radiation Treatment System for Image Guidance and Treatment Adaptation

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).

Study Overview

• Status: Completed
• Conditions: Head and Neck Cancer; Thoracic Cancer; Abdominal Cancer; Pelvic Cancer
• Intervention / Treatment: Device: HyperSight Imaging

• Study Type: Interventional
• Enrollment (Actual): 46
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5G 2M9
      • Princess Margaret Cancer Centre (University Health Network)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patient age is ≥ 18 years old.
• Patient has a diagnosis of primary or metastatic cancer, including but not limited to tumors arising from or involving the head/neck, lungs, liver, pancreas, prostate, urinary bladder, rectum, cervix or uterus.
• A previous (standard-of-care) decision was made to treat the patient with radiation therapy using a Varian TrueBeam treatment system.
• A previous (standard-of-care) decision was made to treat the patient with a radiation dose of at least 20 Gy in at least 5 fractions, one fraction per day on consecutive days, Monday to Friday.
• Patient is willing and able to provide informed consent to participate in the study.

Exclusion Criteria:

• 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").

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: HyperSight Imaging arm; Subjects have both HyperSight and conventional CBCT imaging.	Device: HyperSight Imaging; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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).

Secondary Outcome Measures

Outcome Measure	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.	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).

Collaborators and Investigators

• Sponsor: Varian, a Siemens Healthineers Company

Study record dates

Study Major Dates

• Study Start (Actual): October 17, 2024
• Primary Completion (Actual): April 23, 2026
• Study Completion (Actual): April 23, 2026

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: August 27, 2024
• First Posted (Actual): August 29, 2024

Study Record Updates

• Last Update Posted (Actual): May 6, 2026
• Last Update Submitted That Met QC Criteria: May 4, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Pelvic Neoplasms; Head and Neck Neoplasms
• Other Study ID Numbers: VAR-2023-07

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes